Soln Wash
This should be run once a day to prevent protein build up or at 8 hour intervals if the ISE module performs more than 50 samples per day. Cleaning solution may be aspirated from a sample…
This should be run once a day to prevent protein build up or at 8 hour intervals if the ISE module performs more than 50 samples per day. Cleaning solution may be aspirated from a sample cup but the cup must be covered between use to eliminate evaporation and ensure accuracy.
Who Else Makes It
Concentrated in Jiangsu (1), Hubei (1), Henan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Autobio Labtec Instruments Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | JJF |
| Device type | Analyzer, Chemistry, Micro, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2170 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-26 |
| Record revised | 2025-05-12 (version 4) |
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 |
| Storage | Storage environment temperature 15 to 25 °C; Special storage condition: Stable for 1 month when stored tightly sealed at +2 to +8°C once reconstituted. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RX4003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diamedix | Diamedix Corp. | 2 |
| Spotcheck | Astoria-Pacific, Inc. | 2 |
| Cholestech LDX™ | Alere San Diego, Inc. | 2 |
| AWS | Randox Laboratories Limited | 1 |
| Liaison® XL | Diasorin Inc. | 1 |
| COBAS®TaqMan® 48 Analyzer | Roche Molecular Systems, Inc. | 1 |
| Wash conc. 1 | Randox Laboratories Limited | 1 |
| NS | Randox Laboratories Limited | 1 |
| Liaison® Easy Starter Kit | Diasorin S.P.A | 1 |
| Rabs | Randox Laboratories Limited | 1 |
| Cl Soln | Randox Laboratories Limited | 1 |
| Wash Concentrate 2 | Medtest DX | 1 |
Showing 12 of 26. All products under Analyzer, Chemistry, Micro, For Clinical Use
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.