4 catalogue numbers from UR22002, listed by Microgenics Corporation, United States, under Urinalysis Controls (Assayed And Unassayed). 3 manufacturers in China are registered for this product code.
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 MAS® UrichemTRAK Liquid Assayed Urine Control | Listed by | Microgenics Corporation, 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, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-04-26 |
| Record revised | 2024-12-30 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry 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.