Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and…
Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol® epoc® Calibration Verification Fluids is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for Eurotrol® epoc® Calibration Verification Fluids | 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) | K121468 |
| Record published | 2018-07-11 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing 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.