BioPlex 2200
BioPlex 2200 Syphilis Total & RPR Control Lot Data
12manufacturers in China registered for this device type
22catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jilin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Sejoy Biomedical Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 5 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
| Changsha Sinocare Inc. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | JJX |
| Device type | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K183446 |
| Record published | 2016-09-12 |
| Record revised | 2021-07-29 (version 7) |
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, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 1.5 ml |
| Distribution end date | 2021-07-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6632030 | 6 Vials | In distribution |
| 12000653 | 6 Vials | In distribution |
| 12006555 | 1 Each | In distribution |
| 6631930 | Total Volume 1.5 ml | In distribution |
| 6632130 | Total Volume 1.5 ml | In distribution |
| 12000678 | Total Volume 1.5 ml | In distribution |
| 12000673 | 1 Each | In distribution |
| 12006554 | Total Volume 1.5 ml | In distribution |
| 6632230 | 6 Vials | In distribution |
| 6632330 | Total Volume 1.5 ml | In distribution |
| 12000879 | Total Volume 1.5 ml | In distribution |
| 12000880 | 1 Each | In distribution |
| 12000654 | 1 Each | In distribution |
| 6632340 | 1 Each | In distribution |
| 6632140 | 1 Each | In distribution |
| 6631940 | 1 Each | In distribution |
| 6632240 | 1 Each | In distribution |
| 6633730 | 4 Vials | In distribution |
| 6633740 | 1 Each | In distribution |
| 6632040 | 1 Each | In distribution |
| 6633840 | 1 Each | Withdrawn |
| 6633830 | Total Volume 1.5 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 55 |
| Validate | LGC Clinical Diagnostics, Inc. | 37 |
| Architect | Abbott Laboratories | 24 |
| Architect | Abbott Medical | 23 |
| Architect | Abbott Ireland | 18 |
| Liquichek | Bio-Rad Laboratories Inc. | 17 |
| Alinity | Abbott Medical | 17 |
| Alinity | Abbott Ireland | 15 |
| Fora | Fora Care Inc. | 15 |
| Pregnancy-Skreen | Biochemical Diagnostics, Inc. | 14 |
| Accurun® | LGC Clinical Diagnostics, Inc. | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 9 |
Showing 12 of 907. All products under Single (Specified) Analyte Controls (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123798 | 2013-01-09 |
| K043584 | 2005-02-08 |
| K953883 | 1995-11-14 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-05-13 | Class III | Incorrect or no expiration date | The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error. | 20 vials | 2015-11-05 |
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.