M1298/100

Organization name

GeneProof a.s.

SRN

CZ-MF-000002370

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Czechia; available across 16 countries total.

Trade name

not provided

UDI-DI code

08594161955221

Basic UDI-DI

B-08594161955221

Reference / catalog number

M1298/100

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The kit is intended for detection of the single nucleotide adenine/cytosine polymorphism in site 1298 (A1298C). Clinical specimen is whole blood. The kit can be used in combination with a manual or automated extraction system. The kit is designed for human in vitro diagnostics and provides qualitative detection of presence of wild-type or mutant allele. The kit is intended for diagnostics and aid to diagnosis, and it is designed for professional use in laboratories with trained staff. The target population is the EU population.

Additional information URL

https://www.geneproof.com/products

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0106010116OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)