Inhibin a Elisa
Inhibin A ELISA 4 Plates (384 Tests)
2manufacturers in China registered for this device type
2catalogue numbers in this listing
3recalls on this code
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 | Beckman Coulter, 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, Manufacturer, Exporter |
| Record published | 2016-09-09 |
| Record revised | 2018-03-29 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSL-10-28100-1 | In distribution | |
| DSL-10-28100-4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Dimension Vista® Flex® reagent cartridge E2 | Siemens Healthcare Diagnostics Inc | 1 |
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 |
|---|---|---|---|---|---|
| 2010-12-21 | Not classified | Pending | The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit. | 740 total units for both products | 2012-08-31 |
| 2010-12-21 | Not classified | Pending | The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit. | 740 total units for both products | 2012-08-31 |
| 2010-11-10 | Not classified | Other | The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Elisa kit (Part Number DSL-10-28100-4), kit lot number 110761. | 342 units | 2012-07-11 |
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.