Plasma Calibration Standard
Plasma Calibration Standard Benzodiazepines, Tricyclic Antidepressants
3manufacturers in China registered for this device type
15catalogue 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 | 2019-03-22 |
| Record revised | 2019-04-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Packaging | Pack of 5 |
| Distribution end date | 2024-12-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28007 | 5 x 2,5ml | In distribution |
| 5009 | 10x 2.5ml | In distribution |
| 49031 | 5 x 2.5ml | In distribution |
| 25005 | 5 x 1ml | In distribution |
| 61003 | 5 x 1ml | In distribution |
| 49034 | 5 x 2.5ml | In distribution |
| 46003 | 5 x1ml | In distribution |
| 49035 | 5 x 2.5ml | In distribution |
| 26003 | 5 x 2.5ml | In distribution |
| 59003 | 5 x 2.5ml | In distribution |
| 36005 | 5 x 1ml | In distribution |
| 27034 | 5 x 1ml | In distribution |
| 49032 | 5 x 2.5ml | Withdrawn |
| 49003 | 5 x 2.5ml | Withdrawn |
| 49033 | 5 x 2.5ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 32 |
| Plasma Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 22 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 20 |
| Nova | Nova Biomedical Corporation | 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.