Nucleic acid library construction kit IVD - UK MHRA Medical Device Registration
Nucleic acid library construction kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 100871. The device is manufactured by BGI Europe A/S from Denmark, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company 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
Nucleic acid library construction kit IVD
Type
IVD Annex II List B
Date Registered
Nov 26, 2024
Last Updated
Oct 8, 2023
Relationship Type
Address
3rd Floor, 70 Gracechurch Street
London, England, United Kingdom
Postcode: EC3V 0HR
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
D-dimer IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Nucleic acid sequencing reagent kit IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human infectome analysis interpretive software IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Nucleic acid extraction/isolation kit IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cancer-related multiple gene mutation profile kit IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human genomic analysis interpretive software
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human genomic analysis interpretive software IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry/liquid chromatography (LC/MS)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Patient surgical drape, single-use
Type: General Medical Device
Manufacturer: CareMax Co., Ltd.
Adult nappy
Type: General Medical Device
Manufacturer: Carmelton (Jiangmen) Healthcare Limited
Incontinence pants liner
Type: General Medical Device
Manufacturer: Carmelton (Jiangmen) Healthcare Limited
Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Accucise Diagnostics Inc.
Interleukin-6 (IL-6) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Accucise Diagnostics Inc.
Procalcitonin (PCT) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Accucise Diagnostics Inc.
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Accucise Diagnostics Inc.
Progesterone IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Accucise Diagnostics Inc.
Total human chorionic gonadotropin IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Accucise Diagnostics Inc.
Patient surgical drape, single-use
Type: General Medical Device
Manufacturer: CareMax Co., Ltd.

