Identity
- Trade Name
- Quantra QPlus System FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
- Device Name
- Quantra Quality Control Level 2 Kit FDA UDI
- Model / Reference
- KT-0034 FDA UDI
- Description
- Quantra Quality Control Level 2 Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850003761081 FDA UDI
- 510(k) Number
- DEN180017 FDA UDI
- FDA Product Code
- QFR FDA UDI
- GMDN Term
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5430 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Quantra QPlus System by Hemosonics LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hemosonics LLC
Sources (1)
- FDA UDI 407f9670-f280-4a69-bf41-1489c6894d74 35 fields · synced Jun 8, 2026