Identity
- Trade Name
- Thermo Scientific Pacific Hemostasis® FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
- Model / Reference
- 100600 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845275000825 FDA UDI
- 510(k) Number
- K023362 FDA UDI
- FDA Product Code
- GIS FDA UDI
- GMDN Term
- Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Fibrinogen assay (factor I) IVD, kit, clotting
Thermo Scientific Pacific Hemostasis® by Fisher Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibrinogen assay (factor I) IVD, kit, clotting.
- TriniCLOT™ Thrombin Time 4ml — TCOAG IRELAND LIMITED · Class II
- TriniCLOT™ Imidazole Buffer — TCOAG IRELAND LIMITED · Class II
- Dade Fibrinogen Determination Reagents — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Fibrinogen Assay Kit — Helena Laboratories, Corp. · Class II
- TriniCLOT™ Thrombin Time 1ml — TCOAG IRELAND LIMITED · Class II
- Fibrotek — R2 DIAGNOSTICS, INC. · Class II
- TriniCLOT™ Fibrinogen 6 mL — TCOAG IRELAND LIMITED · Class II
- TriniCAL™ Fibrinogen — TCOAG IRELAND LIMITED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fisher Diagnostics
Sources (1)
- FDA UDI ec6bcd21-fa1b-42bf-acaf-f11b3191891d 35 fields · synced May 30, 2026