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Pacific Hemostasis High Fibrinogen Control Plasma
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 100607, J100607
by Fisher Diagnostics A division of Fisher Scientific Company, LLC
Identity
- Trade Name
- Thermo Scientific Pacific Hemostasis® FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, control FDA UDI
- Device Name
- Pacific Hemostasis High Fibrinogen Control Plasma EUDAMED
- Model / Reference
- 100607, J100607 EUDAMED100607 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845275000610 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845275000610 EUDAMED
- 510(k) Number
- K000679 FDA UDI
- FDA Product Code
- GGN FDA UDI
- EMDN Code
- W0103020201 FIBRINOGEN ASSAYS (FACTOR I) EUDAMED
- GMDN Term
- Fibrinogen assay (factor I) IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Pacific Hemostasis High Fibrinogen Control Plasma by Fisher Diagnostics A division of Fisher Scientific Company, LLC — Class IVD General — IVDD, FDA UDI…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00845275000610 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- EUDAMED SRN
- US-MF-000029041
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (3)
- EUDAMED 3aa84648-3d5f-4b7f-b760-8d336230ed9d 61 fields · synced Jun 18, 2026
- FDA UDI 3f188ba4-5f71-4445-9bfc-f454b0e84ae7 35 fields · synced May 29, 2026
- EUDAMED 3aa84648-3d5f-4b7f-b760-8d336230ed9d-1 61 fields · synced Jun 10, 2026