Alinity Mp
Alinity mp SurePath Holder, Replacement
5manufacturers in China registered for this device type
10catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Zhejiang Biorear Biotechnology Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Abbott Molecular, Inc., United States |
|---|---|
| FDA product code | JQW |
| Device type | Station, Pipetting And Diluting, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2750 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-05-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Special storage condition: Ambient (15-30C) |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 09N65-23 | 20 | In distribution | |
| 09N65-004 | In distribution | ||
| 09N65-008 | In distribution | ||
| 09N65-007 | In distribution | ||
| 09N65-003 | In distribution | ||
| 09N65-002 | In distribution | ||
| 09N65-21 | In distribution | ||
| 09N65-001 | In distribution | ||
| 09N65-22 | In distribution | ||
| 09N65-005 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Caplugs/Evergreen | Caplugs, Inc. | 37 |
| Janus G3 | Caliper Life Sciences, Inc. | 31 |
| Fontus | Caliper Life Sciences, Inc. | 8 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| Quaero | Zhejiang Biorear Biotechnology Co., Ltd. | 5 |
| Freedom EVO® | Tecan Schweiz AG | 5 |
| Q-Prep | Beckman Coulter, Inc. | 4 |
| Janus G3 Blood iQ | Caliper Life Sciences, Inc. | 4 |
| Globe Scientific | Globe Scientific, LLC | 4 |
| Janus G3 Automated Workstation | Caliper Life Sciences, Inc. | 3 |
| PhD lx | Bio-Rad Laboratories Inc. | 3 |
| BD MicroProbe™ Processor | Becton, Dickinson AND Company | 3 |
Showing 12 of 150. All products under Station, Pipetting And Diluting, For Clinical Use
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 |
|---|---|---|---|---|---|
| 2012-01-31 | Class II | Error in labeling | In the Abbott Molecular Bar Code Scanner User’s Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code | 100 units | 2012-12-04 |
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.