Identity
- Trade Name
- INNOVANCE Anti-Xa FDA UDI
- Generic Name
- Coagulation factor Xa inhibitor/heparin activity reagent kit IVD FDA UDI
- Device Name
- In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. FDA UDI
- Model / Reference
- 10873942 FDA UDI
- Description
- In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. FDA UDI
Identifiers
- Catalog Number
- 10873942 FDA UDI
- Primary DI / UDI-DI
- 00630414640204 FDA UDI
- 510(k) Number
- K240315 FDA UDI
- FDA Product Code
- QLU FDA UDI
- GMDN Term
- Coagulation factor Xa inhibitor/heparin activity reagent kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7295 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation factor Xa inhibitor/heparin activity reagent kit IVD
INNOVANCE Anti-Xa by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor Xa inhibitor/heparin activity reagent kit IVD.
Cleared under the same submission
K240315 also covers:
- INNOVANCE Anti-Xa — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Apixaban Controls — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Apixaban Controls — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Apixaban Standard — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Apixaban Standards — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 65b12a98-5e26-4e32-9088-5204bbed43d9 37 fields · synced Jun 1, 2026