Catalogue number 10309925, listed by Siemens Healthcare Diagnostics Inc, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for Rapidqc® Complete Level 1 | Listed by | Siemens Healthcare Diagnostics Inc, United States |
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K970956 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store away from direct sunlight; Storage environment temperature 18 to 25 °C |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 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.