CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended…
CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. A box of CueSee® VeriSTAT LVM contains 5 levels of control material: CueSee® VeriSTAT LVM Level 1 – 08718734961413 CueSee® VeriSTAT LVM Level 2 – 08718734961420 CueSee® VeriSTAT LVM Level 3 – 08718734961437 CueSee® VeriSTAT LVM Level 4 – 08718734961444 CueSee® VeriSTAT LVM Level 5 – 08718734961451
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for CueSee® VeriSTAT LVM | 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 |
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.