5-HIAA Elisa
Enzyme immunoassay for the in vitro diagnostic quantitative determination of 5-HIAA in human urine.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Hubei. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Chenkang Science Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 1 |
Record
| Listed by | DRG Instruments Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | CDA |
| Device type | Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1390 |
| Premarket notification | Exempt |
| Record published | 2021-07-28 |
| Record revised | 2023-07-26 (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 | 2022-06-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-1886 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Reagent | Chromsystems Instruments & Chemicals Gmbh | 11 |
| Reagent Kit | Chromsystems Instruments & Chemicals Gmbh | 3 |
| Serotonin Elisa | DRG International, Inc. | 1 |
| Serotonin Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| Accessorie | Chromsystems Instruments & Chemicals Gmbh | 1 |
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.