Qor Labs
AT Digital Centrifuge, 8-Place Rotor, Fixed Speed
37manufacturers in China registered for this device type
3catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (9), Zhejiang (7), Guangdong (6). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Shanghai Gene Era Bio-Science Co., Ltd. | Fengxian | Shanghai | Contract manufacturer | 8 |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan | Guangdong | Contract manufacturer | 5 |
| Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Showing 12 of 37. All 37 manufacturers in China registered for Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Record
| Listed by | LW Scientific, Inc., United States |
|---|---|
| FDA product code | JQC |
| Device type | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Remanufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-04-09 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| QLC-1606-77T3 | In distribution | |
| ATC-U8AD-15T3 | In distribution | |
| QLC-1606-B7T3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thermo Scientific | Thermo Electron LED GmbH | 131 |
| Yingtai | Changsha Yingtai Instrument Co., Ltd. | 39 |
| Globe Scientific | Globe Scientific, LLC | 33 |
| Swing-out rotor | Andreas Hettich Gmbh | 28 |
| LW Scientific, Inc` | LW Scientific, Inc. | 23 |
| Angle rotor | Andreas Hettich Gmbh | 21 |
| Bucket | Andreas Hettich Gmbh | 21 |
| Harvest® SmartPrep® | Terumo BCT, Inc.. | 12 |
| LW Scientific | LW Scientific, Inc. | 12 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 9 |
| ART BMC System Centrifuge | Celling Biosciences | 9 |
| Harvest® | Terumo BCT, Inc.. | 8 |
Showing 12 of 635. All products under Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2019-02-06 | Class II | Device Design | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area. | 16 units | 2021-05-07 |
| 2019-02-06 | Class II | Device Design | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area. | 142 units | 2021-05-07 |
| 2019-02-06 | Class II | Device Design | The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area. | 226 units | 2021-05-07 |
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.