Identity
- Trade Name
- INNOVANCE® Antithrombin FDA UDI
- Generic Name
- Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI
- Device Name
- Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma FDA UDI
- Model / Reference
- 10487304 FDA UDI
- Description
- Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma FDA UDI
Identifiers
- Catalog Number
- OPFH07 FDA UDI
- Primary DI / UDI-DI
- 00842768027024 FDA UDI
- FDA Product Code
- JBQ FDA UDI
- GMDN Term
- Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7060 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: Antithrombin III (ATIII) IVD, kit, chromogenic
The INNOVANCE Antithrombin device is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma, used to monitor thrombosis risk and guide treatment.
Similar devices
Also classified as Antithrombin III (ATIII) IVD, kit, chromogenic.
- STA® - Stachrom® AT III 3 — DIAGNOSTICA STAGO, INC. · Class II
- ACTICHROME ATIII KIT — Biomedica ADI Inc. · Class II
- TriniCHROM™ Antithrombin Xa — TCOAG IRELAND LIMITED · Class II
- BIOPHEN Antithrombin 5 — HYPHEN BIOMED · Class II
- BIOPHEN Antithrombin 2.5 — HYPHEN BIOMED · Class II
- INNOVANCE Antithrombin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- INNOVANCE Antithrombin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Berichrom Antithrombin III (A) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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 bc50a7a0-7e26-4888-b7c7-f94cd7d41a0a 36 fields · synced Jul 1, 2026