Dimension Vista® Flex® Reagent Cartridge E2
LOCI Estradiol Flex® reagent cartridge, 320 Tests
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | NDR |
| Device type | Enzyme Immunoassay, Inhibin-A |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1260 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10489099 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Inhibin A Elisa | Beckman Coulter, Inc. | 2 |
| Dimension Vista® Multi 1 Sdil | Siemens Healthcare Diagnostics Inc | 1 |
| AutoDELFIA Inhibin A kit Level Calibrators | Wallac OY | 1 |
| AutoDELFIA Inhibin A kit | Wallac OY | 1 |
| Access Inhibin A | Beckman Coulter, Inc. | 1 |
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.