Architect
Quantia Ferritin/Myoglobin/IgE Control
1manufacturer
7catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JJS |
| Device type | Controls For Blood-Gases, (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K050493 |
| Record published | 2016-09-09 |
| Record revised | 2024-02-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not freeze controls.; Handling environment temperature up to 29 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6K56-21 | In distribution | |
| 6K45-02 | In distribution | |
| 06K5004 | In distribution | |
| 06K5622 | In distribution | |
| 6K39-40 | In distribution | |
| 6K47-02 | In distribution | |
| 6K50-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 16 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 11 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Blood Gas and Electrolyte Control | Edan Instruments, Inc. | 3 |
| VKR-7 | Radiometer America, Inc. | 1 |
| Mission Control, Level 1 | Diamond Diagnostics Inc. | 1 |
| Autocheck 3+, Level 1, S7335 | Radiometer Medical APS | 1 |
| Autocheck 3+, Level 4, S7365 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 4 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 3 | Radiometer Medical APS | 1 |
| QC Adaptor | Radiometer Medical APS | 1 |
| Qualicheck 4+, Level 2 | Radiometer Medical APS | 1 |
Showing 12 of 45. All products under Controls For Blood-Gases, (Assayed And Unassayed)
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.