Identity
- Trade Name
- ST art® FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory, semi-automated FDA UDI
- Model / Reference
- 58230 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450582307 FDA UDI
- 510(k) Number
- K904297 FDA UDI
- FDA Product Code
- GKP FDA UDI
- GMDN Term
- Coagulation analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5400 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coagulation analyser IVD, laboratory, semi-automated
ST art® by Diagnostica Stago, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Diagnostica Stago, Inc.
Sources (1)
- FDA UDI 9f0d0195-cd64-41d6-b391-425a3da26565 33 fields · synced Jun 1, 2026