Identity
- Trade Name
- INNOVANCE Heparin FDA UDI
- Generic Name
- Heparin anti-Xa IVD, kit, chromogenic FDA UDI
- Device Name
- For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) FDA UDI
- Model / Reference
- 10873930 FDA UDI
- Description
- For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) FDA UDI
Identifiers
- Catalog Number
- 10873930 FDA UDI
- Primary DI / UDI-DI
- 00630414639864 FDA UDI
- 510(k) Number
- K162540 FDA UDI
- FDA Product Code
- KFF FDA UDI
- GMDN Term
- Heparin anti-Xa IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7525 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: Heparin anti-Xa IVD, kit, chromogenic
INNOVANCE Heparin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heparin anti-Xa IVD, kit, chromogenic.
- Stachrom® Heparin — DIAGNOSTICA STAGO, INC. · Class II
- HR-ACT — MEDTRONIC, INC. · Class II
- BIOPHEN HEPARIN 3 — HYPHEN BIOMED · Class II
- LR-ACT — MEDTRONIC, INC. · Class II
- RACT — MEDTRONIC, INC. · Class II
- ACTICHROME HEPARIN (ANTI-FXA) — Biomedica ADI Inc. · Class II
- Coamatic Heparin — INSTRUMENTATION LABORATORY COMPANY · Class II
- STA® - Liquid Anti-Xa 4 — DIAGNOSTICA STAGO, INC. · Class II
Cleared under the same submission
K162540 also covers:
- INNOVANCE Heparin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin Calibrator — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin Calibrator — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin LMW Control 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin LMW Control 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin LMW Control 2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin LMW Control 2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin UF Control 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin UF Control 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin UF Control 2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- INNOVANCE Heparin UF Control 2 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI d5fad477-5625-4471-b316-d61b19960e39 37 fields · synced May 30, 2026