Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 151407. The device is manufactured by BRAHMS GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Thermo Fisher Diagnostics 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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 151407•Ref: 151407

Device Type

In Vitro Diagnostic Device

Devices

Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 3, 2024

Manufacturer Information

Name

BRAHMS GmbH

Address

Neuendorfstr. 25

Hennigsdorf, Germany

Created Date

Jul 11, 2022

Authorized Representative

Name

Thermo Fisher Diagnostics Ltd.

Relationship Type

UK Responsible Person

Address

Stafford House Boundary Way

Hemel Hempstead, England, United Kingdom

Postcode: HP27GE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from BRAHMS GmbH (10)

Other Products from Same Authorized Representative (10)

Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

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

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Alpha-fetoprotein (AFP) IVD, calibrator

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Alpha-fetoprotein (AFP) IVD, reagent

Arginine vasopressin IVD, kit, fluorescent immunoassay

Atrial natriuretic peptide (ANP) IVD, calibrator

Atrial natriuretic peptide (ANP) IVD, kit, fluorescent immunoassay

Buffered wash solution IVD, automated/semi-automated system

Cancer antigen 125 (CA125) IVD, calibrator

Atrial natriuretic peptide (ANP) IVD, calibrator

Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry

Albumin IVD, calibrator

Albumin IVD, kit, spectrophotometry

Apolipoprotein A-I (Apo A1) IVD, reagent

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator

C-reactive protein (CRP) IVD, calibrator

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Calcium (Ca2+) IVD, kit, spectrophotometry

Carbon dioxide (CO2) IVD, kit, spectrophotometry

Pipette tip IVD