Carolina Liquid Chemistries Corp.® Hdld Reagent Product NO. DT616
HDLD (HDL Cholesterol Direct) w/ calibrator 4 x 250 tests
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Carolina Liquid Chemistries, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-10-17 |
| Record revised | 2023-07-06 (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; Special storage condition: Reagent is stable when stored at 2-8° C until expiration date |
| Sizes | Total volume 12 to 63 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DT616 | Total Volume 63 ml | 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 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Alinity | Abbott Medical | 2 |
| ox-LDL Elisa | Immundiagnostik, Inc. | 2 |
| ACE | Alfa Wassermann | 2 |
Showing 12 of 30. All products under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132711 | 2014-05-08 |
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.