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IVDeology UKRP Ltd

Authorized Representative in the United Kingdom

Maidstone Innovation Centre Gidds Pond Way

Maidstone, England, United Kingdom

Postcode: ME14 5FY

Relationship Type: UK Responsible Person
233 Products Represented
13 Manufacturers
Total Products
233
Manufacturers
13
Device Types
1
Generic Names
190
Manufacturer Portfolio
Products organized by manufacturer
101 Products

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Device ID: 205646
Nov 26, 2024

Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)

Device ID: 114361
Nov 26, 2024

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Device ID: 163489
Nov 26, 2024

Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device ID: 87933
Nov 26, 2024

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

Device ID: 171953
Nov 26, 2024
View all 101 products from this manufacturer →
41 Products

Pethidine IVD, control

Device ID: 88255
Nov 26, 2024

Phenobarbital IVD, control

Device ID: 88247
Nov 26, 2024

Carisoprodol IVD, control

Device ID: 88256
Nov 26, 2024

Ketamine/ketamine metabolite IVD, control

Device ID: 88252
Nov 26, 2024

Methylphenidate metabolite IVD, control

Device ID: 88261
Nov 26, 2024
View all 41 products from this manufacturer →
33 Products

Helicobacter pylori immunoglobulin A (IgA) antibody IVD, control

Device ID: 142745
Nov 26, 2024

Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Device ID: 142728
Nov 26, 2024

Hepatitis E virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Device ID: 142726
Nov 26, 2024

Hepatitis E virus total antibody IVD, control

Device ID: 142749
Nov 26, 2024

Multiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD, control

Device ID: 142744
Nov 26, 2024
View all 33 products from this manufacturer →
16 Products

Oxalate IVD, calibrator

Device ID: 85113
Nov 26, 2024

Oxalate IVD, reagent

Device ID: 85115
Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry

Device ID: 85110
Nov 26, 2024

Total bile acid IVD, kit, enzyme spectrophotometry

Device ID: 85107
Nov 26, 2024

Angiotensin converting enzyme (ACE) IVD, reagent

Device ID: 85105
Nov 26, 2024
View all 16 products from this manufacturer →
14 Products

Angiotensin converting enzyme (ACE) IVD, control

Device ID: 125024
Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device ID: 125029
Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device ID: 125036
Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device ID: 125023
Nov 26, 2024

Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA)

Device ID: 125033
Nov 26, 2024
View all 14 products from this manufacturer →
8 Products

Inherited haemoglobinopathy IVD, calibrator

Device ID: 124716
Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Device ID: 124711
Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Device ID: 124712
Nov 26, 2024

Inherited haemoglobinopathy IVD, control

Device ID: 124714
Nov 26, 2024

Inherited haemoglobinopathy IVD, reagent

Device ID: 124715
Nov 26, 2024
View all 8 products from this manufacturer →
Diagam SA

Belgium

7 Products

Buffered sample diluent IVD, automated/semi-automated system

Device ID: 149171
Nov 26, 2024

Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Device ID: 187038
Nov 26, 2024

Haptoglobin IVD, kit, nephelometry/turbidimetry

Device ID: 194472
Nov 26, 2024

Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Device ID: 184155
Nov 26, 2024

Immunoglobulin M subclass (IgM subclass) IVD, kit, nephelometry/turbidimetry

Device ID: 184156
Nov 26, 2024
View all 7 products from this manufacturer →
5 Products

HIV1 nucleic acid IVD, control

Device ID: 185176
Nov 26, 2024

Hepatitis C virus nucleic acid IVD, control

Device ID: 185175
Nov 26, 2024

West Nile virus nucleic acid IVD, control

Device ID: 185173
Nov 26, 2024

Hepatitis B virus nucleic acid IVD, control

Device ID: 185178
Nov 26, 2024

Hepatitis E virus nucleic acid IVD, control

Device ID: 185174
Nov 26, 2024
3 Products

Oral/respiratory tract specimen container IVD, additive/medium

Device ID: 151345
Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Device ID: 151346
Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, reagent

Device ID: 173176
Nov 26, 2024
2 Products

Total immunoglobulin E (IgE total) IVD, reagent

Device ID: 192512
Nov 26, 2024

Total immunoglobulin E (IgE total) IVD, calibrator

Device ID: 192513
Nov 26, 2024
1 Products

Venous blood collection kit IVD

Device ID: 201334
Nov 26, 2024
Immunostics Inc.

United States

1 Products

Faecal occult blood IVD, kit, colorimetric dipstick

Device ID: 159832
Nov 26, 2024
1 Products

Microbial culture plate imaging/analysis system IVD

Device ID: 172967
Nov 26, 2024
All Represented Products (233)
Complete portfolio registered with MHRA

Venous blood collection kit IVD

Manufacturer:

genEplanet d.o.o.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Angiotensin converting enzyme (ACE) IVD, control

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin A (IgA) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus total antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Borrelia species total antibody IVD, kit, immunoblot

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

Diagam SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ceruloplasmin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Diagam SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Echinococcus granulosus total antibody IVD, kit, complement fixation test (CFT)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erthrocyte sedimentation rate (ESR) analyser IVD

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erthrocyte sedimentation rate (ESR) analyser IVD

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, control

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, colorimetric dipstick

Manufacturer:

Immunostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pethidine IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phenobarbital IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 nucleic acid IVD, control

Manufacturer:

Biologicals Quality Control B. V,

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated erythrocyte sedimentation rate (ESR) tube IVD

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intrinsic factor/parietal cell antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple rheumatoid arthritis-associated antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phospholipid antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

TNF-alpha inhibitor antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carisoprodol IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methylphenidate metabolite IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antifungal therapeutic drug monitoring IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited haemoglobinopathy IVD, calibrator

Manufacturer:

Trinity Biotech (Primus Corporation dba Trinity Biotech)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Manufacturer:

Trinity Biotech (Primus Corporation dba Trinity Biotech)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Trinity Biotech (Primus Corporation dba Trinity Biotech)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited haemoglobinopathy IVD, control

Manufacturer:

Trinity Biotech (Primus Corporation dba Trinity Biotech)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited haemoglobinopathy IVD, reagent

Manufacturer:

Trinity Biotech (Primus Corporation dba Trinity Biotech)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine/methamphetamine group IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple therapeutic drugs/drugs of abuse IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vitamin IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nortriptyline IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus total antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Borrelia species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Borrelia species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin E (IgE total) IVD, reagent

Manufacturer:

Biomed Labordiagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haptoglobin IVD, kit, nephelometry/turbidimetry

Manufacturer:

Diagam SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Diagam SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoglobulin M subclass (IgM subclass) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Diagam SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

Manufacturer:

Diagam SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus nucleic acid IVD, control

Manufacturer:

Biologicals Quality Control B. V,

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

West Nile virus nucleic acid IVD, control

Manufacturer:

Biologicals Quality Control B. V,

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Angiotensin converting enzyme (ACE) IVD, calibrator

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxalate IVD, calibrator

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxalate IVD, reagent

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, kit, enzyme spectrophotometry

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erthrocyte sedimentation rate (ESR) analyser IVD

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, control

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Leptospira species total antibody IVD, kit, complement fixation test (CFT)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple rheumatoid arthritis-associated antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae total antibody IVD, kit, complement fixation test (CFT)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tick-borne encephalitis (TBE) virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

miDiagnostics nv

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

miDiagnostics nv

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii total antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Angiotensin converting enzyme (ACE) IVD, reagent

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, kit, radioimmunoassay

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxalate IVD, control

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxalate IVD, kit, enzyme spectrophotometry

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, control

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, reagent

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Trinity Biotech (Primus Corporation dba Trinity Biotech)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cotinine (nicotine metabolite) IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethanol (ETOH) IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anticonvulsant therapeutic drug monitoring IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple steroid hormone IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxycodone IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zolpidem IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microbial culture plate imaging/analysis system IVD

Manufacturer:

Clever Culture Systems AG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Clark Laboratories, INC., dba Trinity Biotech USA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG)/IgM antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, calibrator

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin E (IgE total) IVD, calibrator

Manufacturer:

Biomed Labordiagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Diagam SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, control

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, colorimetric

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence

Manufacturer:

Trinity Biotech Plc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, reagent

Manufacturer:

miDiagnostics nv

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antidepressant therapeutic drug monitoring IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1C) analyser IVD

Manufacturer:

Trinity Biotech (Primus Corporation dba Trinity Biotech)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin analyser IVD, laboratory

Manufacturer:

Trinity Biotech (Primus Corporation dba Trinity Biotech)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buprenorphine IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lead IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methotrexate therapeutic drug monitoring IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methylmalonic acid (MMA) IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Morphine/morphine metabolite IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple heavy metal IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Opiate/opiate metabolite IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phencyclidine (PCP) IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Propoxyphene IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus nucleic acid IVD, control

Manufacturer:

Biologicals Quality Control B. V,

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus nucleic acid IVD, control

Manufacturer:

Biologicals Quality Control B. V,

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Mycoplasma pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Diesse Diagnostica Senese Spa

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Multiple-therapy therapeutic drug monitoring IVD, control

Manufacturer:

UTAK Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 23, 2024

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Mikrogen GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Jun 3, 2024

Data sourced from the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

Last updated: December 2025