United Kingdom MHRA device registration 115393

Multiple-type clinical chemistry analyte profile IVD, calibrator

United Kingdom·In Vitro Diagnostic Device·Roche Diagnostics GmbH·Registered Nov 26, 2024

Registration details

Device ID: 115393
MHRA Reference Number: 115393
Date Registered: Nov 26, 2024
Last Updated: Oct 10, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple-type clinical chemistry analyte profile IVD, calibrator
Type: Class A

Manufacturer

Name: Roche Diagnostics GmbH
Address: Sandhofer Strasse 116
Mannheim, Germany
Created Date: Apr 19, 2021

Authorized Representative

Name: Roche Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Roche Diagnostics Limited Charles Avenue
Burgess Hill, West Sussex, United Kingdom
Postcode: RH15 9RY

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 Roche Diagnostics GmbH

Additional devices registered by the same manufacturer

Free thyroxine (FT4) IVD, calibratorMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213250

Coagulation factor XII IVD, kit, clottingMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213253

Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassayMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213247

Glucose IVD, controlMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213240

Prothrombin time (PT) IVD, kit, rapid clotting, clinicalMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213256

Coagulation factor XIII IVD, kit, clottingMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213254

Interferon gamma release IVD, kit, enzyme immunoassay (EIA)Mar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213242

Coagulation factor IX IVD, kit, clottingMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213251

von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetryMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213248

Urine protein IVD, kit, rapid colorimetric, clinicalMar 13, 2025

Type: In Vitro Diagnostic Device

Device ID: 213245

Other products from same authorized representative

Additional devices represented by Roche Diagnostics Limited in the UK

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 191747

Human parechovirus (HPeV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 204532

Familial hypercholesterolaemia IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 135829

Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 138725

Hereditary haemochromatosis IVD, primerNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 135839

Human parainfluenza virus 2 nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 204543

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 135830

Beta-fibrinogen mutation IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 204539

Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 191748

MERS-CoV nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: TIB Molbiol Syntheselabor Gmbh

Device ID: 204535

About this record

Multiple-type clinical chemistry analyte profile IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 115393. The device is manufactured by Roche Diagnostics GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics 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