NS
This product should be used in conjunction with RX series reagents to dilute samples prior to assay
3manufacturers in China registered for this device type
1catalogue number
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 | Special storage condition: Once opened the reagent is stable for 1 month on board the analyser at approximately +10°C.; Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA3854 | 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 |
| Soln Wash | Randox Laboratories Limited | 1 |
| Wash conc. 1 | 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.