Alinity
Alinity i DHEA-S Reagent Kit 200 Tests
3manufacturers in China registered for this device type
1catalogue number
1recall
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 | Abbott Medical, United States |
|---|---|
| FDA product code | JKC |
| Device type | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1245 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-04-11 |
| Record revised | 2021-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09P3720 | 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 |
| Elecsys Dhea-S | Roche Diagnostics Gmbh | 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 |
Showing 12 of 45. All products under Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-12-14 | Class II | Device Design | Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old. | 10,153 units | 2018-10-10 |
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.