Identity
- Trade Name
- Specimen Diluent EUDAMEDFDA UDI
- Generic Name
- Platelet factor 4 IVD, reagent FDA UDI
- Device Name
- Specimen Diluent EUDAMEDFor Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G) FDA UDI
- Model / Reference
- 403602 EUDAMEDFDA UDI
- Description
- For Use with PF4 Enhanced (X-HAT13 & X-HAT45) and PF4 IgG (HAT13G & HAT45G) FDA UDI
Identifiers
- Catalog Number
- 403602 FDA UDI
- Primary DI / UDI-DI
- 10888234500353 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823411W0103020402C01CUH EUDAMED
- Direct Marketing DI
- 10888234500353 EUDAMED
- FDA Product Code
- LCO FDA UDI
- EMDN Code
- W0103020402 PLATELET FACTOR 4 EUDAMED
- GMDN Term
- Platelet factor 4 IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7695 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
No
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
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
Specimen Diluent by Immucor GTI Diagnostics, Inc. — Class A — 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 | 88823411W0103020402C01CUH | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Immucor GTI Diagnostics, Inc
- EUDAMED SRN
- US-MF-000020921
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED a5bb5cdc-1a7b-4d96-b6ee-f18df208dcce 61 fields · synced May 31, 2026
- FDA UDI 019c4aad-c2a6-4e42-bff7-333847c95097 36 fields · synced May 29, 2026