Identity
- Trade Name
- QStat Cartridge FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Device Name
- For Use with the QUANTRA® Hemostasis Analyzer FDA UDI
- Model / Reference
- QStat Cartridge KIT (Box of 10) FDA UDI
- Description
- For Use with the QUANTRA® Hemostasis Analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850003761180 FDA UDI
- 510(k) Number
- K213917 FDA UDI
- GMDN Term
- Coagulation analyser IVD, laboratory FDA UDI
Classification
- 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
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
Yes
FDA UDI
Category: Coagulation analyser IVD, laboratory
QStat Cartridge by Hemosonics LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation analyser IVD, laboratory.
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
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- Actalyke Mini II, w/ Printer, w/o Battery, "CE 2009" (110V/220V) — Helena Laboratories, Corp. · Class II
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION · Class II
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Helena Electronic Clotting Tube — Helena Laboratories, Corp. · Class I
- Actalyke Thermometer — Helena Laboratories, Corp. · Class I
Cleared under the same submission
K213917 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Hemosonics LLC
Sources (1)
- FDA UDI 40e1a072-6851-4fc0-ace9-f7c7e9f8eba5 36 fields · synced May 31, 2026