United Kingdom MHRA device registration 89522

Cytomegalovirus (CMV) nucleic acid IVD, calibrator

United Kingdom·In Vitro Diagnostic Device·Abbott Molecular Inc.·Registered Nov 26, 2024

Registration details

Device ID: 89522
MHRA Reference Number: 89522
Date Registered: Nov 26, 2024
Last Updated: Apr 25, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Cytomegalovirus (CMV) nucleic acid IVD, calibrator
Type: IVD Annex II List B

Manufacturer

Name: Abbott Molecular Inc.
Address: 1350 E. Touhy Ave
Des Plaines, IL, Illinois, United States
Created Date: Mar 29, 2021

Authorized Representative

Name: Abbott Laboratories Limited
Relationship Type: UK Responsible Person
Address: Abbott House, Vanwall Business Park, Vanwall Road
Maidenhead, Berkshire, England, United Kingdom
Postcode: SL64XE

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

Other products from Abbott Molecular Inc.

Additional devices registered by the same manufacturer

B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, probeNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114710

B-cell malignancy IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114723

B-cell malignancy IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114711

BK virus (BKV) nucleic acid IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 180900

Cancer/tumour-associated aneuploidy IVD, probeNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114728

Cytology specimen container IVD, transport bufferNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114692

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 89524

Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 71183

Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 71187

Acute myeloid leukaemia (AML) genetic mutation IVD, probeNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 114709

Other products from same authorized representative

Additional devices represented by Abbott Laboratories Limited in the UK

C-peptide IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories Diagnostics Division

Device ID: 107776

Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories Diagnostics Division

Device ID: 107740

Deionization water purification systemNov 26, 2024

Type: General Medical Device

Manufacturer: Abbott Laboratories

Device ID: 136033

Reticulocyte count IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories

Device ID: 141508

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories Diagnostics Division

Device ID: 107743

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories Diagnostics Division

Device ID: 107738

Biological stain IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories

Device ID: 141512

Buffered sample diluent IVD, automated/semi-automated systemNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories

Device ID: 141494

Microscope slide maker/stainer IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories

Device ID: 141500

Digoxin therapeutic drug monitoring IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Abbott Laboratories Diagnostics Division

Device ID: 107728

About this record

Cytomegalovirus (CMV) nucleic acid IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 89522. The device is manufactured by Abbott Molecular Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Abbott Laboratories Limited.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device