Identity
- Trade Name
- AU FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- ISE Reference Solution FDA UDI
- Model / Reference
- AUH1013 FDA UDI
- Description
- ISE Reference Solution FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590140052 FDA UDI
- FDA Product Code
- JGS 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
- 862.1665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Au by Beckman Coulter, 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
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI b30eed1a-5917-420b-84bd-fe458ca4e7b5 33 fields · synced Jun 8, 2026