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
- 10873911 FDA UDI
- Description
- Chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma FDA UDI
Identifiers
- Catalog Number
- 10873911 FDA UDI
- Primary DI / UDI-DI
- 00630414639796 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
INNOVANCE Antithrombin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Berichrom Antithrombin III (A) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- INNOVANCE® Antithrombin — 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 31d673a0-4c75-466d-bbd8-0b705e82a414 36 fields · synced May 30, 2026