Identity
- Trade Name
- H.P.C. (Human Platelet Concentrate) EUDAMEDFDA UDI
- Generic Name
- Multiple human platelet antigen (HPA) typing IVD, kit, agglutination FDA UDI
- Device Name
- H.P.C. (Human Platelet Concentrate) EUDAMEDH.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials. FDA UDI
- Model / Reference
- 0057320 EUDAMEDFDA UDI
- Description
- H.P.C. (Human Platelet Concentrate) is used to reduce or remove HLA (Bg) activity from serum as an aid in antibody detection and identification. H.P.C. is a dry preparation of a washed pool of platelets from individual human platelet donors. This product is a dry preparation which must be rehydrated before use. This product configuration has ten (10) vials. FDA UDI
Identifiers
- Catalog Number
- 0057320 FDA UDI
- Primary DI / UDI-DI
- 10888234001027 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W01030399C030005L EUDAMED
- FDA Product Code
- MYP FDA UDI
- EMDN Code
- W0103030399 ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER EUDAMED
- GMDN Term
- Multiple human platelet antigen (HPA) typing IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
H.P.C. (Human Platelet Concentrate) by Immucor, Inc. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88823401W01030399C030005L | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED 4579fbcb-d10f-4ee5-8797-d80e82d72b3b 61 fields · synced Jun 18, 2026
- FDA UDI 4f58da61-ab5b-4ec4-8603-637280b534c0 37 fields · synced May 30, 2026