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ThromboType®1

FDA UDI

Class II (US FDA UDI)

by Immucor GTI Diagnostics, Inc.

Identity

Trade Name
ThromboType®1 FDA UDI
Generic Name
Multiple human platelet antigen (HPA) typing IVD, kit, multiplex FDA UDI
Device Name
ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA. FDA UDI
Model / Reference
THROMBOTYPE1 FDA UDI
Description
ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA. FDA UDI

Identifiers

Catalog Number
THROMBOTYPE1 FDA UDI
Primary DI / UDI-DI
10888234500261 FDA UDI
FDA Product Code
MYP FDA UDI
GMDN Term
Multiple human platelet antigen (HPA) typing IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II 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: Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

ThromboType®1 by Immucor GTI Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple human platelet antigen (HPA) typing IVD, kit, multiplex.

Cleared under the same submission

BK050040 also covers:

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 31ff4f43-c98d-4baa-a7dd-4888a828c607 37 fields · synced May 31, 2026