Multi-modality clinical specimen analysis system IVD - UK MHRA Medical Device Registration
Multi-modality clinical specimen analysis system IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 132650. 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.
Device Type
In Vitro Diagnostic Device
Devices
Multi-modality clinical specimen analysis system IVD
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
Oct 10, 2024
Relationship Type
Address
Roche Diagnostics Limited Charles Avenue
Burgess Hill, West Sussex, United Kingdom
Postcode: RH15 9RY
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Prothrombin time (PT) IVD, kit, rapid clotting, clinical
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Coagulation factor XIII IVD, kit, clotting
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Interferon gamma release IVD, kit, enzyme immunoassay (EIA)
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Coagulation factor IX IVD, kit, clotting
Type: In Vitro Diagnostic Device
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von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry
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Registered: Mar 13, 2025
Urine protein IVD, kit, rapid colorimetric, clinical
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Basic/simple nutrient broth culture medium IVD
Type: In Vitro Diagnostic Device
Manufacturer: Roche Molecular Systems Inc.
Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
Type: In Vitro Diagnostic Device
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Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
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Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Roche Molecular Systems Inc.
BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Roche Molecular Systems Inc.
Buffered wash solution IVD
Type: In Vitro Diagnostic Device
Manufacturer: Roche Molecular Systems Inc.
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Roche Molecular Systems Inc.
Dried plasma spot collection card IVD
Type: In Vitro Diagnostic Device
Manufacturer: Roche Molecular Systems Inc.
Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer
Type: In Vitro Diagnostic Device
Manufacturer: Roche Molecular Systems Inc.
Assay container IVD, single-use
Type: In Vitro Diagnostic Device
Manufacturer: Roche Molecular Systems Inc.

