Identity
- Trade Name
- CueSee VeriSTAT® FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- CueSee VeriSTAT® S3 is an unassayed quality control material for professional use to verify the performance characteristics of the Abbott i-STAT® system analyzer. The device is intended for the quantitative determination of blood gases (pH, pO2, pCO2), electrolytes (Na+, K+, Ca2+, Cl-), metabolites (glucose, lactate, creatinine, urea), tCO2 and hematocrit. FDA UDI
- Model / Reference
- S3 FDA UDI
- Description
- CueSee VeriSTAT® S3 is an unassayed quality control material for professional use to verify the performance characteristics of the Abbott i-STAT® system analyzer. The device is intended for the quantitative determination of blood gases (pH, pO2, pCO2), electrolytes (Na+, K+, Ca2+, Cl-), metabolites (glucose, lactate, creatinine, urea), tCO2 and hematocrit. FDA UDI
Identifiers
- Catalog Number
- AN01902A03 FDA UDI
- Primary DI / UDI-DI
- 08718734962540 FDA UDI
- FDA Product Code
- OHQ 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
CueSee VeriSTAT® by Eurotrol B.V. — 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
- Eurotrol B.V.
Sources (1)
- FDA UDI 5545c864-048f-49b5-b9a5-70462e2aa600 34 fields · synced Jun 1, 2026