Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Shandong and Zhejiang: 2 hold an FDA registration.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Hangzhou Lysun Biotechnology Co., Ltd. Zhejiang

What Is FDA Product Code CDT?

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides is FDA product code CDT, Class 1, 21 CFR 862.1705.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 20 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Device Design (6), Nonconforming Material/Component (3) and Software design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglyceride LiquiColor®

For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Dimension® Flex® Reagent Cartridge Trig

Triglycerides Flex® reagent cartridge, 480 tests

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Atellica CH Trig

Triglycerides (Trig) Atellica CH - RGT 2000T

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

MedTest DX Triglycerides for the BS200

For the in vitro quantitative determination of Triglycerides in serum or plasma using the Mindray BS-200 analyzer. 4 x 40ml.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Teco Diagnostics Triglyceride Reagent Kit TC-Matrix

Teco Diagnostics Triglyceride Reagent Kit TC-Matrix is used for the quantitative determination of triglycerides in serum on TC Matrix analyzers.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

PTS Panels® Triglycerides Test Strips

PTS Panels® Triglycerides test strips are in vitro diagnostic devices used to monitor triglycerides levels in human whole blood. These test strips must be used in conjunction with a…

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglyceride

Catalogue number SK236-10, listed by Sekisui Diagnostics, LLC, United States, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Advia® Chemistry Trig Triglycerides Reagents

Triglyceride - ADVIA Chem. - RGT - 4x575/4x450 tests

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglycerides Reagent

For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in the diagnosis and treatment of atherosclerosis, poorly…

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Pointe Scientific, Inc. Triglyceride

Pointe Scientific, Inc. Triglyceride Reagent is for the in vitro quantitative determination of Triglycerides in serum or plasma. Packaged for use on Olympus Analyzers. 12 x 65ml

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Pointe Scientific, Inc. Triglycerides

Triglycerides Reagent is for the quantitative determination of triglycerides in serum or plasma on Hitachi analyzers. For in vitro diagnostic use only. 12 x 65ml.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Architect

Catalogue number 7D74-22, listed by Abbott Medical, United States, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglyceride

For the in vitro quantitative determination of Triglycerides in serum or plasma.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Carolina Liquid Chemistries Corp.® Triglyceride Reagent KIT BL213

Triglycerides (TRIG)

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Carolina Liquid Chemistries Corp.® Triglycerides Reagent KIT DT213

Triglycerides (TRIG) Reagent

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglyceride LiquiColor® (Mono)

For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Pointe Triglyceride Reagent

Pointe Triglyceride Reagent packaged for use on the Mindray BA800. 8 x 65ml. For the in vitro quantitative determination of Triglycerides in serum or plasma.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

ACE

Triglycerides Reagent

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Sirrus® Triglyceride LiquiColor®

For the Quantitative Colorimetric Determination of Triglycerides in Serum and Plasma.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Advia® Chemistry TRIG_2 Triglyceride_2 Reagent

ADVIA Chemistry TRIG_2 is a laboratory reagent for quantitatively measuring triglycerides in serum or plasma on the ADVIA 1800 Chemistry System. It is supplied as a ready to use liquid in…

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

AU

5 catalogue numbers from OSR61118, listed by Beckman Coulter, Inc., United States, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Dimension Vista® Flex® Reagent Cartridge Trig

Triglyceride Flex® reagent cartridge, 600 tests

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Pointe Triglycerides Reagent

Pointe Triglycerides Reagent packaged for use on the Mindray BS480. 8 x 60ml. For the in vitro quantitative determination of Triglycerides in serum or plasma.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Point Scientific

Triglyceride Reagent Set for the in vitro quantitative determination of Triglycerides in serum or plasma. Packaged 1 x 500ml

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Synermed®

Triglycerides Reagent 1 X 55 mL + 1 powder wedge

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

MedTest DX Triglycerides for the BS480

For the in vitro quantitative determination of Triglycerides in serum or plasma using the Mindray BS-480 analyzer. 8 x 60ml.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Architect

Catalogue number 7D74-21, listed by Abbott Laboratories, United States, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

ClearChem Diagnostics Inc. Triglycerides

Catalogue number TRG1400, listed by Clearchem Diagnostics Inc., under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Atellica CH Trig_2

Triglycerides_2 (Trig_2) Atellica CH Assay 2000 Tests

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Precimat Glycerol

Catalogue number 10166588130, listed by Roche Diagnostics Gmbh, Germany, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Alinity

Alinity c Triglyceride Reagent Kit

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Teco Diagnostics Triglyceride – GPO Liquid Reagent Set

Teco Diagnostics Triglyceride - GPO Liquid Reagent Set is used for the in vitro quantitative determination of triglycerides in serum.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Teco Diagnostics Triglyceride -GPO Reagent Set

Teco Diagnostics Triglyceride -GPO Reagent Set is used for the quantitative determination of triglycerides in serum or plasma.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Trig Reagent Kit

Triglycerides Reagent Kit for use with EasyRA Analyzers

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglyceride-SL

2 catalogue numbers from 236-60, listed by Sekisui Diagnostics, LLC, United States, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Pointe Scientifc, Inc.

Triglycerides Standard, intended for use as an triglyceride standard for standardization or calibration of enzymatic / GPO trinder triglyceride procedures. Size: 1 x 15 mL. Concentration:…

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Pointe Scientific, Inc.

Triglyceride Standard intended for use as an triglyceride standard for standardization or calibration of enzymatic / GPO trinder triglyceride procedures. Packaged 1 x 15ml

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Glycerol (GLY)

Catalogue number GY105, listed by Randox Laboratories Limited, United Kingdom, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Synchron

Triglycerides Reagent (TG 2 x 300)

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

IDG/Sanzay

For the in vitro quantitative determination of Triglycerides in serum or plasma.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

ABX Pentra Triglycerides CP

Catalogue number 1220001640, listed by Horiba ABX SAS, France, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Advia® Chemistry TRIG_c Reagent

Triglyceride - ADVIA Chem. - Conc. RGT - 4x1063/4x971 tests

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Yumizen C1200 Triglycerides

Catalogue number 1300023867, listed by Horiba ABX SAS, France, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglycerides/Glycerol Blanked

2 catalogue numbers from 05976006190, listed by Roche Diagnostics Gmbh, Germany, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglycerides (Trigs)

For the quantitative in vitro determination of Triglycerides in serum.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Vitros

VITROS XT Chemistry Products TRIG-CHOL Slides

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Triglycerides

4 catalogue numbers from 20767107322, listed by Roche Diagnostics Gmbh, Germany, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

JAS Diagnostics

TRIGLYCERIDES LIQUID (1 x 1 Liter + 1 x 5 mL Standard)

Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Biobase

20 catalogue numbers from R:40mL×4, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides. 2 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer