Identity
- Trade Name
- Hemochron Whole Blood Coagulation System FDA UDI
- Generic Name
- Multiple coagulation factor IVD, reagent FDA UDI
- Device Name
- Kaolin Heparin Response Test 40 tubes/box FDA UDI
- Model / Reference
- R-HRT480PK FDA UDI
- Description
- Kaolin Heparin Response Test 40 tubes/box FDA UDI
Identifiers
- Catalog Number
- R-HRT480PK FDA UDI
- Primary DI / UDI-DI
- 10711234202081 FDA UDI
- 510(k) Number
- K010193 FDA UDI
- FDA Product Code
- KFF FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7525 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
Yes
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: Multiple coagulation factor IVD, reagent
Hemochron Whole Blood Coagulation System by Accriva Diagnostics Holdings, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Accriva Diagnostics Holdings, Inc.
Sources (2)
- FDA UDI 7ff92fe0-0037-4be7-b980-05fc2c1d81d5 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 29, 2026