Elecsys Dhea-S
2 catalogue numbers from 3000087122, listed by Roche Diagnostics Gmbh, Germany, under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate). 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Guangdong (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 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JKC |
| Device type | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1245 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-18 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3000087122 | In distribution | |
| 07027192190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dhea-S | DRG Instruments Gesellschaft mit beschränkter Haftung | 3 |
| Atellica IM Dheas | Siemens Healthcare Diagnostics Inc | 3 |
| Dhea-S Elisa | DRG International, Inc. | 2 |
| Dhea | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Dhea Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Dehydroepiandrosterone (Dhea) Elisa | American Laboratory Products Company | 2 |
| Architect | Abbott Medical | 2 |
| Dhea-S Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| iFlash-DHEA-S | Shenzhen Yhlo Biotech Co., Ltd. | 1 |
| Dhea-S AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| ST AIA-Pack Dhea-S Sample Diluting Solution | Tosoh Corp. | 1 |
| Immulite®/Immulite® 1000 Systems DHS DHEASO4 Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 1 |
Showing 12 of 45. All products under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K003174 | 2001-01-17 |
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.