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PF4 IgG

FDA UDI

Class II (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name
PF4 IgG FDA UDI
Generic Name
Platelet factor 4 IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum. FDA UDI
Model / Reference
HAT45G FDA UDI
Description
PF4 IgG is a qualitative screening assay for the detection of heparin associated IgG antibodies in human serum. FDA UDI

Identifiers

Catalog Number
HAT45G FDA UDI
Primary DI / UDI-DI
10888234500056 FDA UDI
FDA Product Code
LCO FDA UDI
GMDN Term
Platelet factor 4 IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7695 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: Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

PF4 IgG by Immucor GTI Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Platelet factor 4 IVD, kit, enzyme immunoassay (EIA).

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 f694b444-9593-4098-8f4e-f659fbd57aa8 36 fields · synced May 30, 2026