Identity
- Trade Name
- ABL77 Sci FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- SCi50/30 days Full Sensor cassette, 50 tests, 30 days in use lifetime. BG, Hct and electrolytes, for ABL77 FDA UDI
- Model / Reference
- 945-652 FDA UDI
- Description
- SCi50/30 days Full Sensor cassette, 50 tests, 30 days in use lifetime. BG, Hct and electrolytes, for ABL77 FDA UDI
Identifiers
- Catalog Number
- 945-652 FDA UDI
- Primary DI / UDI-DI
- 05700699456526 FDA UDI
- FDA Product Code
- CHL 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 UDI
- Commercial Distribution
- Not 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
ABL77 Sci by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 a7439f44-48eb-494d-9e8c-7023e4f017e7 37 fields · synced May 30, 2026