Vitros
VITROS Chemistry Products AST Slides
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 | CIT |
| Device type | Nadh Oxidation/Nad Reduction, Ast/Sgot |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-23 |
| 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 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8433815 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 19 |
| AST | Randox Laboratories Limited | 10 |
| JAS Diagnostics | Drew Scientific, Ltd. | 7 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 5 |
| AU | Beckman Coulter, Inc. | 4 |
| Architect | Abbott Ireland | 4 |
| Synchron | Beckman Coulter, Inc. | 4 |
| ACE | Alfa Wassermann | 4 |
| Architect | Abbott Medical | 3 |
| Alinity | Abbott Ireland | 3 |
| Architect | Abbott Laboratories | 3 |
Showing 12 of 62. All products under Nadh Oxidation/Nad Reduction, Ast/Sgot
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K001679 | 2000-06-28 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 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. | 197,552 units (88,537 units domestically & 109,015 units int | 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.