Identity
- Trade Name
- Hemochron Whole Blood Microcoagulation System FDA UDI
- Generic Name
- Prothrombin time (PT) IVD, reagent FDA UDI
- Device Name
- PT Cuvette - 45 test cuvettes/box. FDA UDI
- Model / Reference
- J201 FDA UDI
- Description
- PT Cuvette - 45 test cuvettes/box. FDA UDI
Identifiers
- Catalog Number
- J201 FDA UDI
- Primary DI / UDI-DI
- 10711234103036 FDA UDI
- 510(k) Number
- K940432 FDA UDI
- FDA Product Code
- GJS FDA UDI
- GMDN Term
- Prothrombin time (PT) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7750 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: Prothrombin time (PT) IVD, reagent
Hemochron Whole Blood Microcoagulation System by Accriva Diagnostics Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 59b3d3c3-bda1-431d-8422-524ab6e6ac14 37 fields · synced Jun 6, 2026