Vitros
VITROS Chemistry Products UPRO Performance Verifier II
1manufacturer
3catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | JGP |
| Device type | Lowry (Colorimetric), Total Protein |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1635 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-10 |
| Record revised | 2023-06-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -18 to -18 °C |
| Packaging | Case of 100, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6800120 | In distribution | |
| 6800190 | In distribution | |
| 6800191 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 7 |
| ClearChem Diagnostics Inc. MicroProtein, Total | Clearchem Diagnostics Inc. | 1 |
| JAS Diagnostics | Drew Scientific, Ltd. | 1 |
| Pointe Scientific, Inc. Microprotein Standard | Horiba Instruments Incorporated | 1 |
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 |
|---|---|---|---|---|---|
| 2016-12-08 | Class II | Device Design | There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides. | 37,571 packs/90 slides totalling 3,381,390 slides | 2018-06-22 |
| 2013-06-12 | Class II | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. | 31,395 units (10,864 units domestically & 20,531 units inter | 2017-04-11 |
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.