GSP Neonatal 17α-OH-progesterone Kit
GSP Neonatal 17α-OH-progesterone kit measures 17-OHP in dried blood spots as an aid to newborn screening for congenital adrenal hyperplasia. It is a competitive, time-resolved fluorescence…
GSP Neonatal 17α-OH-progesterone kit measures 17-OHP in dried blood spots as an aid to newborn screening for congenital adrenal hyperplasia. It is a competitive, time-resolved fluorescence immunoassay run on the GSP instrument.
Sample 17-OHP competes with europium-labelled 17-OHP for rabbit-antibody binding sites. A second antibody fixed to the solid phase separates the bound and unbound material.
Listed Item
Time-resolved fluoroimmunoassay for the quantitative determination of 17a-OH-progesterone (17-OHP) in dried blood.
Fluorescence Signal
DELFIA Inducer releases europium from the labelled antigen into fluorescent chelates. The instrument measures the fluorescence in each well; signal intensity is inversely related to the sample’s 17-OHP concentration. The assay uses blood collected and dried on filter paper.
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 | Wallac OY, Finland |
|---|---|
| FDA product code | JLX |
| Device type | Radioimmunoassay, 17-Hydroxyprogesterone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1395 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100682 |
| Record published | 2018-11-16 |
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 |
|---|---|---|
| 3305-001U | In distribution |
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 |
| Salivary 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100682 | 2010-07-23 |
| K081922 | 2009-04-16 |
| K050960 | 2005-07-11 |
| K042425 | 2004-09-30 |
| K042424 | 2004-09-30 |
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.