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Unipath Limited (trading as Alere International)

Authorized Representative in the United Kingdom

Abbott House Vanwall Road Vanwall Business Park

Maidenhead, England, United Kingdom

Postcode: SL6 4XE

Relationship Type: UK Responsible Person
184 Products Represented
9 Manufacturers
Total Products
184
Manufacturers
9
Device Types
2
Generic Names
148
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (184)
Complete portfolio registered with MHRA

Capillary blood transfer tube IVD, heparin

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mechanical micropipette IVD

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Isothermal nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nuclear matrix protein 22 IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD4 cell marker IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

Abbott Rapid Diagnostics Jena GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Manufacturer:

Abbott Rapid Diagnostics Jena GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Manufacturer:

Abbott Rapid Diagnostics Jena GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

6-Acetyl morphine IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buprenorphine IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buprenorphine IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Morphine/morphine metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Opiate/opiate metabolite IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxycodone IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tapentadol IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tapentadol IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis antigen IVD, kit, rapid ICT, clinical

Manufacturer:

ABON Biopharm (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered isotonic saline reagent IVD

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, K2EDTA

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, K2EDTA

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, control

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, control

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, no additive

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoassay reagent vehicle tray IVD, reusable

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus antigen IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, reagent

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nuclear matrix protein 22 IVD, reagent

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Protease IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

6-Acetyl morphine IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine-specific IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Salicylate IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zolpidem IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, control

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Single-channel clinical chemistry analyser IVD, point-of-care

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Single-channel clinical chemistry analyser IVD, point-of-care

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vibrio cholerae antigen (multiple serotype) IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

ABON Biopharm (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Manufacturer:

ABON Biopharm (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine-specific IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buprenorphine IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antidepressant therapeutic drug monitoring IVD, reagent

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection kit

Manufacturer:

Immunalysis Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxycodone IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxycodone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tapentadol IVD, control

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, calibrator

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immunalysis Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Morphine/morphine metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wuchereria bancrofti antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

Abbott Rapid Diagnostics Jena GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, control

Manufacturer:

Abbott Rapid Diagnostics Jena GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buprenorphine IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxycodone IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phencyclidine (PCP) IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cotinine IVD, kit, rapid ICT, clinical

Manufacturer:

Innovacon Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood transfer tube IVD, heparin

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, reagent

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, reusable

Manufacturer:

Alere San Diego, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered isotonic saline reagent IVD

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, reagent

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, control

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, reagent

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, reagent

Manufacturer:

Abbott Diagnostics Technologies AS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoassay reagent vehicle tray IVD, reusable

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Isothermal nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Plasmodium species antigen IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nuclear matrix protein 22 IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) antigen IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, control

Manufacturer:

Abbott Diagnostics Scarborough, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser control unit IVD

Manufacturer:

Abbott Rapid Diagnostics Jena GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Korea, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 18, 2021

HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Manufacturer:

Abbott Diagnostics Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 18, 2021

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

Last updated: December 2025