The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative…
The Piccolo® General Chemistry 6 , used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, gamma glutamyltransferase (GGT), glucose, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
Who Else Makes It
Registered in Zhejiang.
Record
Regulatory record for Piccolo General Chemistry 6 | Listed by | Abaxis, Inc., United States |
| FDA product code | JQB |
| Device type | Kinetic Method, Gamma-Glutamyl Transpeptidase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1360 |
| Establishment | Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2022-12-20 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 36 to 46 °F; Storage environment temperature 2 to 8 °C |
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.