A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains…
A comprehensive cellular component and chemistry analyte urinalysis control designed specifically for the Siemens CLINITEK Atlas® and Sysmex® UF-1000i™ combined urinalysis system. Contains 1 vial each of L-PC,PCM & NC.
Who Else Makes It
Concentrated in Jilin (1), Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for UA-Cellular Complete | Listed by | Streck LLC, United States |
| FDA product code | JJW |
| Device type | Urinalysis Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K131444 |
| Record published | 2016-09-19 |
| Record revised | 2018-07-06 (version 3) |
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 10 °C |
| Sizes | Total volume 120 ml |
| UDI direct marking | Exempt |
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.