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Positive Platelet Control (Positive Eluate Control)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Positive Platelet Control (Positive Eluate Control) FDA UDI
- Generic Name
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent FDA UDI
- Device Name
- For Use with PakAuto FDA UDI
- Model / Reference
- 404579 FDA UDI
- Description
- For Use with PakAuto FDA UDI
Identifiers
- Catalog Number
- 404579 FDA UDI
- Primary DI / UDI-DI
- 10888234500568 FDA UDI
- FDA Product Code
- MYP FDA UDI
- GMDN Term
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent 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
No
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
Positive Platelet Control (Positive Eluate Control) 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
| 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 2042c62a-4541-4182-8900-46249a85fac6 38 fields · synced Jun 8, 2026