Spotcheck
Uridyltransferase Active Cartridge
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Astoria-Pacific, Inc., United States |
|---|---|
| FDA product code | JJF |
| Device type | Analyzer, Chemistry, Micro, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2170 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K883020 |
| Record published | 2016-10-14 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 303-A980-00A | In distribution | |
| 303-A980-00B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diamedix | Diamedix Corp. | 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
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.