Ldl & Vldl Precipitation, Cholesterol via Esterase-Oxidase, Hdl

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Guangdong and Hebei: 2 hold an FDA registration. 1 is a contract manufacturer.

Dongguan BAO Kang Dian ZI KE JI Limited Guangdong, contract manufacturer
Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei

How Is LBS Classified?

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl is FDA product code LBS, Class 1, 21 CFR 862.1475.

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 9 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Device Design (3), Labeling Change Control (1) and Equipment maintenance (1).

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

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Architect

Ultra HDL

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Carolina Liquid Chemistries Corp.® HDL Direct CC615

HDLD W/CALIBRATOR, 2 X 200 tests

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

HDL Cholesterol Reagent Set

The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the…

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

HDL

An HDL-cholesterol test system is a device intended for the quantitative in vitro determination of HDL-cholesterol concentration in human serum and plasma.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Architect

Ultra HDL

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Carolina Liquid Chemistries Corp.® HDL RGT. KIT BL-616

HDLD (High Density Lipoprotein Direct) w/ cal 3 x 100 tests

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

HDL-Cholesterol Gen.4

4 catalogue numbers from 08057877190, listed by Roche Diagnostics Gmbh, Germany, under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. 2 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

HDL Ultra Cholesterol Reagent

Catalogue number SK6122-20, listed by Sekisui Diagnostics, LLC, United States, under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. 2 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Vantera Clinical Analyzer

Clinical Analyzer

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Synchron

HDL Cholesterol Reagent HDL 2 x 200

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

NMR Reference Standard

NMR Reference Standard used for the Vantera Clinical Analyzer.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Carolina Liquid Chemistries Corp.® Hdld Reagent Product NO. DT616

HDLD (HDL Cholesterol Direct) w/ calibrator 4 x 250 tests

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

HDL Ultra Cholesterol

2 catalogue numbers from 6122, listed by Sekisui Diagnostics, LLC, United States, under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. 2 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Sirrus® Direct HDL Cholesterol LiquiColor®

For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

ACE

HDL-C Reagent

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

IDG/Sanzay

The HDL-LDL calibrator is used to establish the value of high density lipoprotein cholesterol and low-density lipoprotein cholesterol for IDG HDL Cholesterol Enzymatic and LDL Cholesterol…

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

AU

LDL-Cholesterol

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Atellica CH Hdlc

HDL Cholesterol (HDLC) Atellica CH Assay 1792 Tests

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol

In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

ox-LDL Elisa

2 catalogue numbers from K 7810.US, listed by Immundiagnostik, Inc., United States, under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. 2 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Synermed®

HDL-Cholesterol Reagent 1 X 240 mL + 1 X 80 mL

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

HDL Chol Reagent Kit

HDL Cholesterol Reagent Kit for use with EasyRA Analyzers

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Alinity

Alinity c Ultra HDL Reagent Kit 1400 Tests

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Direct HDL-Cholesterol (HDL)

Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Atellica™ CH D-HDL

Direct HDL Cholesterol (D-HDL) Atellica™ CH - RGT 1792T

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Direct HDL Cholesterol LiquiColor®

For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Vitros

VITROS Chemistry Products dHDL Slides

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

JAS Diagnostics

HDL CHOLESTEROL (2 x 30mL R1, 2 x 10mL R2, 1 x 3mL Standard)

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents

HDL Cholesterol - ADVIA Chem. - RGT - 4x326 tests

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Ultra N-Geneous HDL Cholesterol Reagent

2 catalogue numbers from 80-6277-00, listed by Sekisui Diagnostics, LLC, United States, under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. 2 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

HDL-Cholesterol Plus 3rd Generation

Catalogue number 05401488190, listed by Roche Diagnostics Gmbh, Germany, under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl. 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