Identity
- Trade Name
- ThromboType® FDA UDI
- Generic Name
- Multiple human platelet antigen (HPA) typing IVD, kit, multiplex FDA UDI
- Device Name
- ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA. FDA UDI
- Model / Reference
- THROMBOTYPE FDA UDI
- Description
- ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA. FDA UDI
Identifiers
- Catalog Number
- THROMBOTYPE FDA UDI
- Primary DI / UDI-DI
- 10888234500285 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
- 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
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
ThromboType® by Immucor GTI Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
BK050040 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immucor GTI Diagnostics, Inc.
Sources (1)
- FDA UDI c6ce24bf-c08c-44b8-8f34-2e0ebf4b23f1 38 fields · synced Jun 1, 2026