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Pak12®

FDA UDI

Class II (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name
Pak12® FDA UDI
Generic Name
Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Pak12 assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX. FDA UDI
Model / Reference
PAK12 FDA UDI
Description
Pak12 assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX. FDA UDI

Identifiers

Catalog Number
PAK12 FDA UDI
Primary DI / UDI-DI
10888234500216 FDA UDI
FDA Product Code
MYP FDA UDI
GMDN Term
Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Commercial Distribution
Not 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

No

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

Pak12® by Immucor GTI Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immucor GTI Diagnostics, Inc.

Sources (1)

  • FDA UDI c556e63c-1636-4490-a862-2d408d77b85c 38 fields · synced Jun 1, 2026