Salivary 17-OH Progesterone Elisa
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
Record
| Listed by | DRG Instruments Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | JLX |
| Device type | Radioimmunoassay, 17-Hydroxyprogesterone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1395 |
| 510(k) | K062534 |
| Record published | 2023-09-01 |
| Record revised | 2024-11-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2024-11-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLV-3140 | In distribution | |
| SLV-3140 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AutoDELFIA Neonatal 17α-OH-progesterone kit | Wallac OY | 3 |
| DBC 17α-Hydroxyprogesterone (17α-OHP) Elisa | Diagnostics Biochem Canada, Inc. | 3 |
| 17 OH-Progesterone Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Progesterone (17-a-OH Progesterone) | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| AccuDiag™ 17-alpha-OH Progesterone Elisa | Diagnostic Automation, Inc. | 1 |
| GSP Neonatal 17α-OH-progesterone kit | Wallac OY | 1 |
| N-17-OHP AccuBind Elisa Test System – 960 Wells | Monobind, Inc. | 1 |
| 17 OH Progesterone Elisa | DRG International, Inc. | 1 |
| N-17-OHP AccuBind Elisa Test System – 96 Wells | Monobind, Inc. | 1 |
| Progesterone (17-a-OH Progesterone) | DRG International, Inc. | 1 |
| N-17-OHP AccuBind Elisa Test System – 480 Wells | Monobind, Inc. | 1 |
| 17OHP AccuLite Clia Test System – 192 Wells | Monobind, Inc. | 1 |
Showing 12 of 35. All products under Radioimmunoassay, 17-Hydroxyprogesterone
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.