Microalbumin (mALB)
Catalogue number MA8056, listed by Randox Laboratories Limited, United Kingdom, under Albumin, Fitc, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Zhejiang (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | DDZ |
| Device type | Albumin, Fitc, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MA8056 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| mALB | Randox Laboratories Limited | 5 |
| Anti Human Albumin Fitc | Kent Laboratories, Inc. | 1 |
| Poly Rb A-Hu Albumin/FITC | Agilent Technologies Singapore (International) Pte Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K002674 | 2000-10-05 |
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 |
|---|---|---|---|---|
| 2024-01-31 | Class II | Under Investigation by firm | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%. | 6 units |
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.