Identity
- Trade Name
- SAE Admin Console Dx Software V1.2.0 Kit FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Model / Reference
- A54068 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302017978 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laboratory instrument/analyser application software IVD
SAE Admin Console Dx Software V1.2.0 Kit by Life Technologies Limited — 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
- Life Technologies Limited
Sources (1)
- FDA UDI 9a7efe8d-51da-4cc6-aebf-b01d5f012c40 32 fields · synced May 30, 2026