Plasma Calibrator Set
3PLUS1® Multilevel Plasma Calibrator Set MassTox® Antidepressants 2/ Psychostimulants/EXTENDED
3manufacturers in China registered for this device type
22catalogue numbers in this listing
2recalls on this code
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 | Chromsystems Instruments & Chemicals Gmbh, Germany |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-01-31 |
| Record revised | 2022-01-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to -18 °C |
| Sizes | Total volume 0.5 to 3 ml |
| Distribution end date | 2022-01-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 92026/XT2 | 4 Vials | In distribution |
| 75128 | Total Volume 0.5 ml | In distribution |
| 61028 | Total Volume 1 ml | In distribution |
| 92025-XT2 | 4 x 1ml | In distribution |
| 92027/XT | Total Volume 1 ml | In distribution |
| 92031 | Total Volume 1 ml | In distribution |
| 58028 | Total Volume 2 ml | In distribution |
| 92025/XT | Total Volume 1 ml | In distribution |
| 92051 | Total Volume 1 ml | In distribution |
| 46039 | Total Volume 1 ml | In distribution |
| 92053 | Total Volume 1 ml | In distribution |
| 92030 | Total Volume 1 ml | In distribution |
| 92033 | Total Volume 1 ml | In distribution |
| 92052 | Total Volume 1 ml | In distribution |
| 92029/XT | Total Volume 1 ml | In distribution |
| 46029 | Total Volume 1 ml | In distribution |
| 46039/XL | Total Volume 1 ml | In distribution |
| 27029 | 4 Vials | In distribution |
| 92032 | Total Volume 1 ml | In distribution |
| 92051/XT | Total Volume 1 ml | In distribution |
| 81039 | Total Volume 3 ml | In distribution |
| 92026/XT | Total Volume 1 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 32 |
| 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
Recalls
2 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 |
|---|---|---|---|---|---|
| 2020-11-02 | Class II | Under Investigation by firm | Products do not meet stability criteria and may impact results. | 200 packaging units | 2021-12-20 |
| 2020-10-29 | Class II | Under Investigation by firm | Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone. | 148 package units |
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.