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Pacific Hemostasis Thromboplastin-D
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref 100356Model 100356, J100356
by Fisher Diagnostics A division of Fisher Scientific Company, LLC
Identity
- Trade Name
- Thermo Scientific Pacific Hemostasis® FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
- Device Name
- Pacific Hemostasis Thromboplastin-D EUDAMED
- Model / Reference
- 100356, J100356 EUDAMED100356 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845275000542 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845275000542 EUDAMED
- 510(k) Number
- K994100 FDA UDI
- FDA Product Code
- GJS FDA UDI
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN TIME EUDAMED
- GMDN Term
- Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7750 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
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
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 Thromboplastin-D by Fisher Diagnostics A division of Fisher Scientific Company, LLC — Class IVD General — FDA_510K, IVDD — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994100 | Class IVD General | Active |
| FDA 510(k) | United States | FDA_510K | K810350 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-00845275000542 | Class IVD General | Active |
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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 a329f57f-a60a-4020-a8db-6e1ea99e79ca 61 fields · synced Oct 6, 2026
- FDA UDI 03cfa53a-8c61-4792-b5a5-512d6eb3c6bb 35 fields · synced May 30, 2026
- FDA 510(k) K994100 1 fields · synced May 18, 2026