Ualb Reagent Kit
Microalbumin Reagent Kit for use with EasyRA Analyzers
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
Record
| Listed by | Medica Corp., United States |
|---|---|
| FDA product code | DCF |
| Device type | Albumin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5040 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K101089 |
| Record published | 2019-02-14 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10225-4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ortho | Ortho-Clinical Diagnostics, Inc. | 4 |
| JAS Diagnostics | Drew Scientific, Ltd. | 2 |
| N Antiserum to Human Albumin | Siemens Healthcare Diagnostics Products GmbH | 2 |
| AU | Beckman Coulter, Inc. | 2 |
| Albumin LiquiColor® | Stanbio Laboratory, L.P. | 1 |
| Microalbumin Assay | Sekisui Diagnostics, LLC | 1 |
| K-Assay® Microalbumin Reagent (L) | Kamiya Biomedical Company LLC | 1 |
| Human Albumin CSF Kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| Microalbuminuria Kit (Immunoturbidimetric Method) | Medicalsystem Biotechnology Co., Ltd. | 1 |
| Yumizen C1200 Albumin U/CSF | Horiba ABX SAS | 1 |
| Microalbumin | Sekisui Diagnostics, LLC | 1 |
| Synchron | Beckman Coulter, Inc. | 1 |
Showing 12 of 35. All products under Albumin, Antigen, Antiserum, Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101089 | 2011-07-13 |
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.