Chemiluminescent immunoassay analyser IVD - UK MHRA Medical Device Registration

Chemiluminescent immunoassay analyser IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 211651. The device is manufactured by Atlas Medical GmbH from Germany, classified as In Vitro Diagnostic Device.

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In Vitro Diagnostic Device

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Chemiluminescent immunoassay analyser IVD

MHRA Device ID: 211651

Device Type

In Vitro Diagnostic Device

Type

IVD General

Status

DREGIY

Date Registered

Feb 24, 2025

Manufacturer Information

Name

Atlas Medical GmbH

Address

Ludwig-Erhard-Ring 3 , 15827 Blankenfelde-Mahlow, Berlin, Germany

BERLIN, Germany

DJ Fang

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Other Products from Atlas Medical GmbH (10)

Chemiluminescent immunoassay analyser IVD - UK MHRA Medical Device Registration

Device Type

Type

Status

Date Registered

Name

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

Multiple clinical chemistry analyser IVD, laboratory

Full blood count IVD, control

Blood culture analyser IVD

Multiple urine analyte IVD, kit, rapid colorimetric, self-testing

Alanine aminotransferase (ALT) IVD, reagent

Albumin IVD, reagent

Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)

1,25-Dihydroxy vitamin D3 IVD, kit, chemiluminescent immunoassay

ABO multiple blood grouping IVD, kit, agglutination

Escherichia coli antigen IVD, kit, rapid ICT, clinical