Alinity
Microalbumin 640 Tests
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
| Jilin Test BIO-Electron Co., Ltd. | Changchun | Jilin | Manufacturer | 9 |
Record
| Listed by | Abbott Ireland, Ireland |
|---|---|
| FDA product code | JIQ |
| Device type | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1645 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-28 |
| Record revised | 2023-10-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature up to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08P0424 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ricca Chemical Company® | Ricca Chemical Company LLC | 4 |
| Architect | Abbott Medical | 3 |
| Immage | Beckman Coulter, Inc. | 1 |
| Autokit Micro Albumin | Fujifilm Wako Pure Chemical Corporation | 1 |
| Alinity | Abbott Medical | 1 |
| Architect | Abbott Ireland | 1 |
| ABX Pentra Urinary Proteins CP | Horiba ABX SAS | 1 |
| Yumizen C1200 Urinary Proteins | Horiba ABX SAS | 1 |
| Synermed® | Infrared Laboratory Systems LLC | 1 |
| Architect | Abbott Laboratories | 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.