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STA-R Evolution® Expert Series (with cap piercing option)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- STA-R Evolution® Expert Series (with cap piercing option) FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Model / Reference
- 58979 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450589795 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Coagulation analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 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
STA-R Evolution® Expert Series (with cap piercing option) by Diagnostica Stago, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082675 also covers:
K093001 also covers:
K983460 also covers:
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 6ad693b0-3c1d-479b-9a04-83076b7d6643 33 fields · synced May 29, 2026