Panels › Clinical Chemistry › Product code CDT · Class 1
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Regulation 862.1705
0510(k)s in 12 months (151 all time)
0recalls in 12 months (20 all time)
13recalls that name a 510(k)
Top companies in CDT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica CH Triglycerides_2: in vitro diagnostic use in the
quantitative determination of triglycerides in human serum and plasma (lithium heparin,
sodium heparin, potassium EDTA) using the Atellica C Open, Classified |
CDT | None listed |
| Aug 29, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica CH Triglycerides (concentrated)-In vitro diagnostic use
in the quantitative measurement of triglycerides in human serum and plasma (lithium
heparin, potassium EDTA) using the Atellica CH Anal Open, Classified |
CDT | K133067 |
| Oct 6, 2021 | Siemens Healthcare Diagnostics, Inc. Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038 Open, Classified |
CDT | K043546 |
| Aug 15, 2019 | Beckman Coulter Inc Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228 Terminated |
CDT | None listed |
| Aug 24, 2018 | Beckman Coulter Inc. Beckman Coulter Lipase, REF OSR6130 and OSR6230. Terminated |
CDT | None listed |
| Mar 2, 2018 | Randox Laboratories Ltd. Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284
Product Usage:
For Professional Use for the quantitative in vitro determination of Lipase in huma Terminated |
CDT | None listed |
| Apr 3, 2017 | Beckman Coulter Inc. Triglycerides Reagent (TG 2 x 300), Catalog No. 445850.
Intended for quantitative determination of triglycerides concentration in human serum or plasma. Terminated |
CDT | None listed |
| Oct 18, 2016 | Randox Laboratories Ltd. Randox Lipase (Colorimetric)
Product Usage:
A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis a Terminated |
CDT | None listed |
| Aug 11, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Terminated |
CDT | K130332 |
| Apr 13, 2016 | Beckman Coulter Inc. Triglyceride, Catalog No. OSR6x118
Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Terminated |
CDT | K063804 |
| Apr 13, 2016 | Beckman Coulter Inc. Lipase, Catalog No. OSR6x30
Product Usage:
Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers. Terminated |
CDT | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Assays: Triglycerides (TRIG) Terminated |
CDT | K061655 |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Assays: Triglycerides (TGL) Terminated |
CDT | K010871 |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT Terminated |
CDT | K133067 |
| Mar 7, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575.
For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemist Terminated |
CDT | K133067 |
| Feb 2, 2016 | Horiba Instruments Inc ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is Terminated |
CDT | K060854 |
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Triglycerides/Glycerol Blanked.
In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems. Terminated |
CDT | K873049 |
| Jan 28, 2015 | Beckman Coulter Inc. Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 Terminated |
CDT | K963424 |
| Dec 22, 2014 | Ortho-Clinical Diagnostics VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD
For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum an Terminated |
CDT | K812029 |
| Mar 24, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for Terminated |
CDT | K043546 K051087 |
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