United Kingdom MHRA device registration 148847

Nucleic acid hybridization detection IVD, kit

United Kingdom·In Vitro Diagnostic Device·Kreatech Biotechnology B.V.·Registered Nov 26, 2024

Registration details

Device ID: 148847
MHRA Reference Number: 148847
Date Registered: Nov 26, 2024
Last Updated: Nov 12, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Nucleic acid hybridization detection IVD, kit
Type: Class A

Manufacturer

Name: Kreatech Biotechnology B.V.
Address: Vlierweg 20
Amsterdam, Netherlands
Created Date: Oct 19, 2021

Authorized Representative

Name: Leica Microsystems (UK) Limited
Relationship Type: UK Responsible Person
Address: Larch House Woodlands Business Park
Milton Keynes, England, United Kingdom
Postcode: MK14 6FG

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 Kreatech Biotechnology B.V.

Additional devices registered by the same manufacturer

Nucleic acid hybridization detection IVD, probeNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 109068

Nucleic acid hybridization detection IVD, kitJul 22, 2024

Type: In Vitro Diagnostic Device

Device ID: 109067

Other products from same authorized representative

Additional devices represented by Leica Microsystems (UK) Limited in the UK

Surgical microscope filter

Type: General Medical Device

Manufacturer: Leica Microsystems (Schweiz) AG

Device ID: 176701

Neurosurgical microscopeNov 26, 2024

Type: General Medical Device

Manufacturer: Leica Microsystems (Schweiz) AG

Device ID: 176699

Cryostat microtome IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Leica Biosystems Nussloch GmbH

Device ID: 149609

Surgical microscope filterNov 26, 2024

Type: General Medical Device

Manufacturer: Leica Microsystems (Schweiz) AG

Device ID: 176700

Surgical microscope fluorescence visualization softwareNov 26, 2024

Type: General Medical Device

Manufacturer: Leica Microsystems (Schweiz) AG

Device ID: 177281

Tissue processor IVD, automated/semi-automatedNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Leica Biosystems Melbourne Pty Ltd

Device ID: 180423

Scope eyepiece attachmentNov 26, 2024

Type: General Medical Device

Manufacturer: Leica Microsystems (Schweiz) AG

Device ID: 198640

Microscope slide coverslipper IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Leica Biosystems Nussloch GmbH

Device ID: 149613

Microscope slide stainer IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Leica Biosystems Nussloch GmbH

Device ID: 109079

LoupeNov 26, 2024

Type: General Medical Device

Manufacturer: Leica Microsystems (Schweiz) AG

Device ID: 125916

About this record

Nucleic acid hybridization detection IVD, kit is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 148847. The device is manufactured by Kreatech Biotechnology B.V. from Netherlands, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Leica Microsystems (UK) 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device