mALB
A Microalbumin test system is a device intended for the quantitative in vitro determination of Microalbumin concentration in human urine
2manufacturers in China registered for this device type
5catalogue numbers in this listing
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 |
| 510(k) | K002674 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MA2426 | In distribution | |
| MA3828 | In distribution | |
| MA8325 | In distribution | |
| MA2423 | In distribution | |
| MA2864 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microalbumin (mALB) | Randox Laboratories Limited | 1 |
| 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Randox Laboratories Limited | 510(k) number | 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.