Vitros
VITROS XT Chemistry Products TRIG-CHOL Slides
2manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Shandong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | CDT |
| Device type | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1705 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-11-13 |
| 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; Special storage condition: Store at or below -18 |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6844292 | In distribution | |
| 1336544 | In distribution | |
| 8329930 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 20 |
| JAS Diagnostics | Drew Scientific, Ltd. | 8 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 7 |
| Synermed® | Infrared Laboratory Systems LLC | 6 |
| AU | Beckman Coulter, Inc. | 5 |
| Triglycerides | Roche Diagnostics Gmbh | 4 |
| Triglycerides (Trigs) | Randox Laboratories Limited | 4 |
| Carolina Liquid Chemistries Corp.® Triglycerides Reagent KIT DT213 | Carolina Liquid Chemistries | 4 |
| Teco Diagnostics Triglyceride – GPO Liquid Reagent Set | Teco Diagnostics | 3 |
| Triglycerides/Glycerol Blanked | Roche Diagnostics Gmbh | 2 |
| Triglyceride-SL | Sekisui Diagnostics, LLC | 2 |
| Teco Diagnostics Triglyceride -GPO Reagent Set | Teco Diagnostics | 2 |
Showing 12 of 48. All products under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130332 | 2013-05-31 |
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 |
|---|---|---|---|---|---|
| 2016-08-11 | Class II | Under Investigation by firm | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. | US: 60,372 sales units; Foreign: 145,611 sales units | 2018-06-11 |
| 2014-11-06 | Class II | Nonconforming Material/Component | Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides. | USA: 380 units, Foreign: 155 units | 2017-02-28 |
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.