Biological stain IVD - UK MHRA Medical Device Registration

Biological stain IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 159073. The device is manufactured by Alpha-Tec Systems, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MDSS-UK RP 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.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Biological stain IVD

MHRA Device ID: 159073•Ref: 159073

Device Type

In Vitro Diagnostic Device

Devices

Biological stain IVD

Type

Class A

Date Registered

Nov 26, 2024

Last Updated

Oct 10, 2023

Manufacturer Information

Name

Alpha-Tec Systems, Inc.

Address

1311 SE Cardinal Court, Suite 170

Vancouver, WA, United States

Created Date

Mar 8, 2022

Authorized Representative

Name

MDSS-UK RP LIMITED

Relationship Type

UK Responsible Person

Address

6 Wilmslow Road, Rusholme

Manchester, England, United Kingdom

Postcode: M14 5TP

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Alpha-Tec Systems, Inc. (10)

Other Products from Same Authorized Representative (10)

Biological stain IVD - 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

Biological stain control IVD

Faecal parasite specimen concentration kit IVD

Faecal specimen container IVD, fixative

Faecal specimen container IVD, no additive

Faecal specimen container IVD, transport buffer/medium

Formalin substitute solution IVD

General specimen microscopy slide IVD, single-use

Neutral buffered formalin IVD

Sputum specimen liquefaction/decontamination kit IVD

Sputum liquefaction/decontamination reagent IVD

Surgical retraction system mounting frame, reusable

Medical cushion cover

Non-wearable urine/faecal collection bag holder

Radiological general body-part positioner

External limb prosthesis finishing component, custom-made

External limb prosthesis finishing component, non-customized

External limb prosthesis finishing component, non-customized

External limb prosthesis socket liner

External lower-limb prosthesis suspensory component, non-powered

Sputum liquefaction/decontamination reagent IVD