Access Dhea-S
The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using…
The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.
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 | Beckman Coulter, Inc., 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, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-09-23 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A10826 | 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K040181 | 2004-03-24 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-09-09 | Not classified | Process control | The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may overstate actual DHEA levels in patient samples. | 3,542 units (1181 in US) | 2012-05-04 |
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.