Identity
- Trade Name
- Hemochron Whole Blood Coagulation System FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
- Device Name
- Temperature Verification Tube FDA UDI
- Model / Reference
- HR1003 FDA UDI
- Description
- Temperature Verification Tube FDA UDI
Identifiers
- Catalog Number
- HR1003 FDA UDI
- Primary DI / UDI-DI
- 10711234540114 FDA UDI
- 510(k) Number
- K990449 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation analyser IVD, point-of-care, line-poweredCoagulation analyser IVD, laboratory, semi-automated
Hemochron Whole Blood Coagulation System by Accriva Diagnostics Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Accriva Diagnostics Holdings, Inc.
Sources (1)
- FDA UDI dd8c11e7-9af6-496c-aa0b-7273ab50d83e 36 fields · synced Jun 6, 2026