PhD Lx
3 catalogue numbers from PhD lx, listed by Bio-Rad Laboratories Inc., United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.
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 | Bio-Rad Laboratories 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-01-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PhD lx | In distribution | |
| PhD lx | In distribution | |
| PhD lx | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Caplugs/Evergreen | Caplugs, Inc. | 37 |
| Janus G3 | Caliper Life Sciences, Inc. | 31 |
| Alinity mp | Abbott Molecular, Inc. | 10 |
| 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 |
| BD MicroProbe™ Processor | Becton, Dickinson AND Company | 3 |
Showing 12 of 150. All products under Station, Pipetting And Diluting, For Clinical Use
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-01-20 | Not classified | Other | Firm’s Correction involves advising customers who have implemented a Laboratory Information System (LIS) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. When a patient re | 650 units | 2011-08-17 |
| 2009-09-29 | Not classified | Software change control | Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the PhD system with software version 2.1A. | 262 units | 2011-03-11 |
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.