The Microbumin Microalbumin Control is intended as a means of monitoring various microalbumin assay methods to validate quantitation of patient samples. It is supplied in two levels, 5x7mL…
The Microbumin Microalbumin Control is intended as a means of monitoring various microalbumin assay methods to validate quantitation of patient samples. It is supplied in two levels, 5x7mL each level per box. They are ready-to-use, liquid, requiring no reconstitution. They are prepared from human urine, fortified to target levels with human albumin and creatinine. Preservatives have been added to inhibit microbial growth.
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 Microbumin Microalbumin Control Level 1&2 Set 10x7mL | Listed by | Quantimetrix Corp., 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, Manufacturer, Exporter |
| 510(k) | K831526 |
| 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 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
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.