The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative…
The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only.
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
Record
Regulatory record for Piccolo Basic Metabolic Panel Plus | Listed by | Abaxis, Inc., United States |
| FDA product code | CFJ |
| Device type | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1440 |
| Establishment | Manufacturer |
| 510(k) | K010670 |
| Record published | 2016-09-23 |
| Record revised | 2022-12-20 (version 5) |
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.