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Pefakit

FDA UDI

Class II (US FDA UDI)

by Pentapharm GmbH

Identity

Trade Name
Pefakit FDA UDI
Generic Name
Activated protein C resistance ratio (APCR) IVD, kit, clotting FDA UDI
Device Name
Plasma based functional assay for the determination of resistance to activated protein C caused by the Factor V Leiden mutation (FV:Q506). FDA UDI
Model / Reference
502-02 FDA UDI
Description
Plasma based functional assay for the determination of resistance to activated protein C caused by the Factor V Leiden mutation (FV:Q506). FDA UDI

Identifiers

Catalog Number
502-02 FDA UDI
Primary DI / UDI-DI
07640175460013 FDA UDI
510(k) Number
K042762 FDA UDI
FDA Product Code
GGW FDA UDI
GMDN Term
Activated protein C resistance ratio (APCR) IVD, kit, clotting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7925 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Activated protein C resistance ratio (APCR) IVD, kit, clotting

Pefakit by Pentapharm GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Activated protein C resistance ratio (APCR) IVD, kit, clotting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pentapharm GmbH

Sources (1)

  • FDA UDI e7847f28-278a-4f7e-8ee5-407ca3e52e49 37 fields · synced Jun 1, 2026