Vitros
VITROS Chemistry Products PROT Slides
3manufacturers in China registered for this device type
2catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | CEK |
| Device type | Biuret (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 | 2016-08-26 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8208431 | In distribution | |
| 8392292 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 17 |
| Synermed® | Infrared Laboratory Systems LLC | 10 |
| JAS Diagnostics | Drew Scientific, Ltd. | 6 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 5 |
| AU | Beckman Coulter, Inc. | 5 |
| Pointe Scientific, Inc. Total Protein | Horiba Instruments Incorporated | 5 |
| Synchron | Beckman Coulter, Inc. | 3 |
| Total Protein 2 (TP 2) | Randox Laboratories Limited | 3 |
| Total Protein | Roche Diagnostics Gmbh | 3 |
| Alinity | Abbott Ireland | 2 |
| Pointe Total Protein Reagent | Horiba Instruments Incorporated | 2 |
| Atellica CH Total Protein_2 | Siemens Healthcare Diagnostics Inc | 2 |
Showing 12 of 61. All products under Biuret (Colorimetric), Total Protein
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2020-12-15 | Class II | Device Design | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides | US= 223,788 ; OUS:=168,120 Totlal: 491,908 | 2021-07-27 |
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 |
|---|---|---|---|---|---|
| 2020-12-15 | Class II | Device Design | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides | US=9802; OUS: 1298 Total: 11,100 | 2021-07-27 |
| 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. | 19,438 units (8,845 units domestically & 10,593 units intern | 2017-04-11 |
| 2003-03-26 | Not classified | Other | Slides may exhibit random, elevated imprecision of results. | 29,273 (domestic); 4,967 (international) | 2004-11-16 |
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.