Identity
- Trade Name
- VKR-5 FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- Kit of QC material for the validation of sensor linear response in ABL90, ABL80 COOX, ABL80 COOX OSM series FDA UDI
- Model / Reference
- VKR-5 FDA UDI
- Description
- Kit of QC material for the validation of sensor linear response in ABL90, ABL80 COOX, ABL80 COOX OSM series FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003561942 FDA UDI
- FDA Product Code
- JJS FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Vkr-5 by Radiometer America, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Radiometer America, Inc.
Sources (1)
- FDA UDI 67c2636d-83ea-4d2a-a455-cb44d7c3deb2 35 fields · synced Jun 1, 2026