Diamedix
MAGO Plus chemistry analyzer
3manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Diamedix Corp., United States |
|---|---|
| FDA product code | JJF |
| Device type | Analyzer, Chemistry, Micro, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2170 |
| Record published | 2016-09-21 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Storage | Handling environment temperature 18 to 30 °C; Handling environment temperature 5 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MAGO Plus | In distribution | |
| MAGO 4S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K973177 | 1997-10-09 |
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.