The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Actim PROM Low Positive Control (40 μg/L) 3. Actim PROM High…
The Actim PROM Controls kit consists of one of each of the following components: 1. Actim PROM Negative Control (0 μg/L) 2. Actim PROM Low Positive Control (40 μg/L) 3. Actim PROM High Positive Control (250 μg/L) 4. Actim Reconstitution Solution 5. Instructions for use
Who Else Makes It
Concentrated in Jiangsu (3), Hunan (1).
Record
Regulatory record for Actim Prom Controls | Listed by | Actim OY, Finland |
| FDA product code | OAM |
| Device type | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1550 |
| Establishment | Manufacturer |
| 510(k) | K123986 |
| Record published | 2019-02-28 |
| Record revised | 2022-09-16 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
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.