The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of monitoring the measurement of conductivity and osmolality by cystic fibrosis screening procedures…
The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of monitoring the measurement of conductivity and osmolality by cystic fibrosis screening procedures and to validate the analysis of Chloride, Potassium, and Sodium by confirmatory methods used to quantitate patient samples. They are liquid, ready-to-use, requiring no reconstitution or dilution. They are supplied in three levels, nine vials per box, 3x3mL each level. They are prepared in an aqueous simulated human sweat matrix to which preservatives have been added.
Who Else Makes It
Concentrated in Jilin (1), Shanghai (1), Chongqing (1).
Record
Regulatory record for Sweat Control Level 1, 2, & 3 Set 9x3mL | Listed by | Quantimetrix Corp., United States |
| FDA product code | JJR |
| Device type | Electrolyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K943925 |
| Record published | 2018-09-26 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature 18 to 25 °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.