Identity
- Trade Name
- COAGULASE PLASMA 15ML EUDAMEDREMEL FDA UDI
- Generic Name
- Coagulase production microbial reagent IVD FDA UDI
- Device Name
- COAGULASE PLASMA EUDAMEDCoagulase Plasma 15ml/VL FDA UDI
- Model / Reference
- R21051 EUDAMEDFDA UDI
- Description
- Coagulase Plasma 15ml/VL FDA UDI
Identifiers
- Catalog Number
- R21051 FDA UDI
- Primary DI / UDI-DI
- 00848838022241 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380CoagulasePlasmaLJ EUDAMED
- FDA Product Code
- JTL FDA UDI
- EMDN Code
- W0105011299 STAPHYLOCOCCI REAGENTS - OTHER EUDAMED
- GMDN Term
- Coagulase production microbial reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2160 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Coagulase Plasma 15ml by Remel, 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 | 8488380CoagulasePlasmaLJ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 488dfb7d-21ae-4122-81ac-2e7ea7cdf3f1 61 fields · synced Jun 19, 2026
- FDA UDI 0b8193dd-125e-4d08-9d59-0281a38ef8e8 34 fields · synced May 30, 2026