Immage
IMMAGE Immunochemistry Systems ALB Albumin Reagent
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
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 | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | DCF |
| Device type | Albumin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5040 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-08-24 |
| Record revised | 2025-08-18 (version 6) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 447600 | 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 |
|---|---|
| K082251 | 2009-04-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-04-24 | Class II | Under Investigation by firm | Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. | 3,158 units total (1,957 units in US) | 2017-12-30 |
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.