Identity
- Trade Name
- STA® - Stachrom® AT III 3 FDA UDI
- Generic Name
- Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI
- Model / Reference
- 00596 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450005967 FDA UDI
- 510(k) Number
- K832592 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
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: Antithrombin III (ATIII) IVD, kit, chromogenic
STA® - Stachrom® AT III 3 by Diagnostica Stago, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Antithrombin III (ATIII) IVD, kit, chromogenic.
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- Berichrom Antithrombin III (A) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- INNOVANCE Antithrombin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago, Inc.
Sources (2)
- FDA UDI 2a131912-afa4-4c51-93eb-abb4ab98e553 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026