Vitros
VITROS Chemistry Products dHDL Slides
2manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | LBS |
| Device type | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-04-18 |
| Record revised | 2023-06-21 (version 2) |
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 | Special storage condition: Can also store 2-8 for up to 12w; Storage environment temperature -18 to -18 °C |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6802469 | In distribution | |
| 6801895 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| JAS Diagnostics | Drew Scientific, Ltd. | 6 |
| Direct HDL-Cholesterol (HDL) | Randox Laboratories Limited | 4 |
| Synermed® | Infrared Laboratory Systems LLC | 4 |
| AU | Beckman Coulter, Inc. | 4 |
| HDL-Cholesterol Gen.4 | Roche Diagnostics Gmbh | 4 |
| Direct HDL Cholesterol LiquiColor® | Stanbio Laboratory, L.P. | 3 |
| Ultra N-geneous HDL Cholesterol Reagent | Sekisui Diagnostics, LLC | 2 |
| Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents | Siemens Healthcare Diagnostics Inc | 2 |
| Alinity | Abbott Medical | 2 |
| ox-LDL Elisa | Immundiagnostik, Inc. | 2 |
| ACE | Alfa Wassermann | 2 |
| HDL Ultra Cholesterol | Sekisui Diagnostics, LLC | 2 |
Showing 12 of 30. All products under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120609 | 2012-09-07 |
| K042006 | 2004-10-28 |
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. | 100.393 units (36,873 units domestically & 63,520 units inte | 2017-04-11 |
| 2012-02-02 | Not classified | Device Design | Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type. | 120,225 of 60-slide count, 11.364 of 18-slide count | 2018-07-05 |
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.