Identity
- Trade Name
- Quantra QPlus System FDA UDI
- Generic Name
- Coagulation analyser IVD, point-of-care, line-powered FDA UDI
- Device Name
- Quantra Desktop Remote Viewer FDA UDI
- Model / Reference
- KT-0039 FDA UDI
- Description
- Quantra Desktop Remote Viewer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850003761107 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
- 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation analyser IVD, point-of-care, line-powered
Quantra QPlus System by Hemosonics LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation analyser IVD, point-of-care, line-powered.
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- directCHECK Whole Blood Controls — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Cleared under the same submission
DEN180017 also covers:
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 1dbed37e-118f-4610-8af3-060cf7af7255 34 fields · synced May 31, 2026