United Kingdom MHRA device registration 125559

Sp-100 protein antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·INOVA Diagnostics ·Registered Nov 26, 2024
Registration details
Device ID
125559
MHRA Reference Number
125559
Date Registered
Nov 26, 2024
Last Updated
Nov 22, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Sp-100 protein antibody IVD, kit, enzyme immunoassay (EIA)
Type
IVD General
Manufacturer
Address
9900 Old Grove Road
San Diego, United States
Created Date
Dec 21, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester
Manchester, England, United Kingdom
Postcode: WA3 6DE
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 INOVA Diagnostics

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by Werfen Ltd in the UK

Adenovirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 189456
Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 138615
Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 189459
Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 138614
Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 189490
Chikungunya virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 147842
Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 138605
Clostridium tetani immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 138611
Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 189487
Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Device ID: 189455
About this record

Sp-100 protein antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125559. The device is manufactured by INOVA Diagnostics from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Werfen Ltd.

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