Coagulation factor II (prothrombin) IVD, control - UK MHRA Medical Device Registration

Coagulation factor II (prothrombin) IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 146624. The device is manufactured by Acon Laboratories, 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

🇬🇧

Coagulation factor II (prothrombin) IVD, control

MHRA Device ID: 146624•Ref: 146624

Device Type

In Vitro Diagnostic Device

Devices

Coagulation factor II (prothrombin) IVD, control

Type

IVD Devices for Self-Testing

Date Registered

Nov 26, 2024

Last Updated

Mar 12, 2024

Manufacturer Information

Name

Acon Laboratories, Inc.

Address

5850 Oberlin Drive, #340

San Diego, CA, United States

Created Date

Mar 31, 2021

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 Acon Laboratories, Inc. (10)

Other Products from Same Authorized Representative (10)

Coagulation factor II (prothrombin) IVD, control - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Free thyroxine (FT4) IVD, kit, fluorescent immunoassay

Multiple respiratory virus antigen IVD, kit, rapid ICT, clinical

Myoglobin IVD, kit, fluorescent immunoassay

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

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

Glucose IVD, control

Haemoglobin detection IVD, control

Urine analyser IVD, laboratory

Urine analyser IVD, point-of-care

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry

High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometry

Ketone (acetoacetate) IVD, control

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical

Abdominal binder, reusable

Clavicle orthosis

Elbow orthosis

Mud-filled chair cushion

Upper-limb mechanical weight exerciser, lever/pulley-cable

Wrist orthosis

ENFit/ENFit linear connector

Luer/non-ISO80369-standardized linear connector, single-use

Surgical plume evacuation system

Cast shoe, reusable