Architect
ARCHITECT PROGESTERONE REAGENT KIT 1 x 500
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
Record
| Listed by | Abbott Ireland, Ireland |
|---|---|
| FDA product code | JLS |
| Device type | Radioimmunoassay, Progesterone |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1620 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-31 |
| Record revised | 2024-02-21 (version 3) |
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 | Handling environment temperature 2 to 8 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7K77-50 | In distribution | |
| 7K77-25 | In distribution | |
| 7K77-35 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MP Biomedicals LLC | Mp Biomedicals, LLC | 4 |
| Elecsys Progesterone III | Roche Diagnostics Gmbh | 3 |
| Alinity | Abbott Ireland | 3 |
| Salimetrics | Salimetrics LLC. | 3 |
| Atellica IM Prge | Siemens Healthcare Diagnostics Inc | 3 |
| Salivary Progesterone Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Immulite®/Immulite® 1000 Systems PRG Progesterone | Siemens Healthcare Diagnostics Products GmbH | 2 |
| Salivary Progesterone HS Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Progesterone Luminescence Immunoassay | IBL International Gmbh | 2 |
| Progesterone Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Pantex | Pantex | 2 |
Showing 12 of 54. All products under Radioimmunoassay, Progesterone
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.