Identity
- Trade Name
- ABL80 SC80 FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- SC80 25/30 BG/Hct, QC3 FDA UDI
- Model / Reference
- 945-770 FDA UDI
- Description
- SC80 25/30 BG/Hct, QC3 FDA UDI
Identifiers
- Catalog Number
- 945-770 FDA UDI
- Primary DI / UDI-DI
- 05700699457707 FDA UDI
- FDA Product Code
- CHL FDA UDIJIX FDA UDIDQA FDA UDIJJY FDA UDICEM FDA UDIJFP FDA UDIJGS FDA UDIGHS FDA UDIJPI FDA UDICGZ FDA UDIGKR FDA UDICGA FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 FDA UDI862.1150 FDA UDI870.2700 FDA UDI862.1660 FDA UDI862.1600 FDA UDI862.1145 FDA UDI862.1665 FDA UDI864.7425 FDA UDI864.6400 FDA UDI862.1170 FDA UDI864.5620 FDA UDI862.1345 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Abl80 Sc80 by Radiometer Medical ApS — 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
- Radiometer Medical ApS
Sources (1)
- FDA UDI e53973d5-ad5f-41b5-983b-0077cfea587a 36 fields · synced Jun 1, 2026