BioPlex 2200
BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
3manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-12 |
| Record revised | 2021-07-29 (version 8) |
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 0.5 ml |
| Distribution end date | 2021-07-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6631920 | 1 Each | In distribution |
| 6633320 | 1 Each | In distribution |
| 12000672 | 1 Each | In distribution |
| 6631320 | 1 Each | In distribution |
| 6633300 | 4 Vials | In distribution |
| 6632000 | 7 Vials | In distribution |
| 6633240 | 1 Each | In distribution |
| 6631200 | 7 Vials | In distribution |
| SW4.1_V1 | 1 Each | In distribution |
| 6631800 | Total Volume 0.5 ml | In distribution |
| 6631600 | Total Volume 0.5 ml | In distribution |
| 12000677 | Total Volume 0.5 ml | In distribution |
| 6632320 | 1 Each | In distribution |
| 6631820 | 1 Each | In distribution |
| 6632200 | Total Volume 0.5 ml | In distribution |
| 12008626 | 1 Each | In distribution |
| 6632300 | 9 Vials | In distribution |
| 6632120 | 1 Each | In distribution |
| 6631620 | 1 Each | In distribution |
| 6632220 | 1 Each | In distribution |
| 6631101 | Total Volume 0.5 ml | In distribution |
| 6631400 | Total Volume 0.5 ml | In distribution |
| 6631420 | 1 Each | In distribution |
| 6631121 | 1 Each | In distribution |
| 6631300 | 2 Vials | In distribution |
| 6632020 | 1 Each | In distribution |
| SW4_V3 | 1 Each | In distribution |
| 6631220 | 1 Each | In distribution |
| 6632100 | Total Volume 0.5 ml | In distribution |
| 6631900 | Total Volume 0.5 ml | In distribution |
| 6633820 | 1 Each | Withdrawn |
| 6633800 | 3 Vials | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| Plasma Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 22 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 20 |
| Nova | Nova Biomedical Corporation | 15 |
| Plasma Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 15 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 15 |
| Architect | Abbott Laboratories | 11 |
| Alinity | Abbott Medical | 10 |
| Synchron | Beckman Coulter, Inc. | 9 |
| Architect | Abbott Medical | 9 |
| Urine Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
| Serum Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture
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.