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PakAuto®

FDA UDI

Class II (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name
PakAuto® FDA UDI
Generic Name
Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma. FDA UDI
Model / Reference
PAKAUTO-MAYO FDA UDI
Description
PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma. FDA UDI

Identifiers

Catalog Number
PAKAUTO-MAYO FDA UDI
Primary DI / UDI-DI
10888234500728 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

PakAuto® 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 807e8f4b-82cd-416d-b4be-d07435281acc 38 fields · synced Jun 1, 2026