CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It…
CueSee® VeriSTAT QC – Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC – Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for CueSee® VeriSTAT QC | Listed by | Eurotrol B.V., Netherlands |
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K131595 |
| Record published | 2020-10-08 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Product box of 10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.