Alba Elution Kit
The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. It is intended for professional use…
The ALBA Elution Kit is intended for use in the acid elution of antibodies from intact red blood cells to allow further detection and/or identification. It is intended for professional use within a blood donor or clinical laboratory environment to perform acid elution of antibodies relating to transfusion in the general population. This pre-analytical procedure is performed manually. The ALBA Elution Kit is an accessory for sample preparation only and does not return diagnostic results for an analyte. The ALBA Elution Kit is Rx only.
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Lilian Precision Mould Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Goju Identification Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Alba Bioscience Limited, United Kingdom |
|---|---|
| FDA product code | KSS |
| Device type | Supplies, Blood-Bank |
| Device class | Class 1 |
| Regulation | 21 CFR 864.9050 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2023-10-13 |
| Record revised | 2026-01-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 2 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Z313U | In distribution |
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Showing 12 of 48. All products under Supplies, Blood-Bank
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.