System, Test, Low Density, Lipoprotein

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Guangxi, Hebei and Shandong: 3 hold an FDA registration.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei
Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer

What Is FDA Product Code MRR?

System, Test, Low Density, Lipoprotein is FDA product code MRR, 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 Has Gone Wrong With It?

The FDA has recorded 9 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Process change control (1), Nonconforming Material/Component (1) and Device Design (1).

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

System, Test, Low Density, Lipoprotein

Sirrus® Direct LDL Cholesterol LiquiColor®

For the qualitative determination of LDL Cholesterol in serum and plasma.

System, Test, Low Density, Lipoprotein

Dimension Vista® Flex® Reagent Cartridge Ldlc

Low-Density Lipoprotein Cholesterol Flex® reagent cartridge, 180 Tests

System, Test, Low Density, Lipoprotein

Atellica CH Ldlc

LDL Cholesterol (LDLC) Atellica CH Assay 1600 Tests

System, Test, Low Density, Lipoprotein

Synchron

Direct LDL Cholesterol Reagent (LDLD 2 x 100)

System, Test, Low Density, Lipoprotein

LDL

In Vitro device for the quantitative determination of LDL-Cholesterol in serum and plasma.

System, Test, Low Density, Lipoprotein

LDL Cholesterol

Catalogue number SK5665-20, listed by Sekisui Diagnostics, LLC, United States, under System, Test, Low Density, Lipoprotein. 3 manufacturers in China are registered for this product code.

System, Test, Low Density, Lipoprotein

Pointe Scientific autoLDL Cholesterol

autoLDL Cholesterol Reagent is for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. 6 x 60ml,…

System, Test, Low Density, Lipoprotein

Atellica CH Dldl

LDL Cholesterol Direct (D LDL) Atellica CH - RGT 1600T

System, Test, Low Density, Lipoprotein

Teco Diagnostics TC-Matrix LDL Cholesterol Reagent Kit

Teco Diagnostics TC-Matrix LDL Cholesterol Reagent Kit is intended for the quantitative determination of low-density lipoprotein (LDL) in human serum and plasma on TC Matrix analyzers.

System, Test, Low Density, Lipoprotein

Teco Diagnostics Direct LDL Cholesterol Reagent Set

Teco Diagnostics Direct LDL Cholesterol Reagent Set is used for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro…

System, Test, Low Density, Lipoprotein

autoLDL

For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only.

System, Test, Low Density, Lipoprotein

N-Geneous LDL-ST Cholesterol Reagent (R2)

2 catalogue numbers from 80-5714-00, listed by Sekisui Diagnostics, LLC, United States, under System, Test, Low Density, Lipoprotein. 3 manufacturers in China are registered for this product code.

System, Test, Low Density, Lipoprotein

MedTest Dx, Inc. autoLDL Cholestrol

Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma using the Mindray BS-480 analyzer. For in vitro diagnostic use…

System, Test, Low Density, Lipoprotein

Vitros

VITROS Chemistry Products dLDL Reagent

System, Test, Low Density, Lipoprotein

Direct LDL Cholesterol LiquiColor®

For the Quantitative Determination of Low Density Lipoprotein (LDL) Cholesterol in Human Serum or Plasma.

System, Test, Low Density, Lipoprotein

ACE

LDL-C Reagent

System, Test, Low Density, Lipoprotein

Dimension® Flex® Reagent Cartridge Aldl

Automated LDL Cholesterol Flex® reagent cartridge, 120 tests

System, Test, Low Density, Lipoprotein

Pointe Scientific, Inc. autoLDL Cholesterol

Pointe Scientific, Inc. autoLDL Cholesterol Reagent is for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma on Olympus…

System, Test, Low Density, Lipoprotein

Direct LDL-Cholesterol (LDL)

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

System, Test, Low Density, Lipoprotein

MedTest Dx, Inc. autoLDL

Reagent for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-200 analyzer. 3 x 40ml, 3 x 14ml

System, Test, Low Density, Lipoprotein

Mercodia Oxidized LDL Elisa

The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma.…

System, Test, Low Density, Lipoprotein

N-Geneous LDL-ST Cholesterol Reagent (R1)

2 catalogue numbers from 80-5727-02, listed by Sekisui Diagnostics, LLC, United States, under System, Test, Low Density, Lipoprotein. 3 manufacturers in China are registered for this product code.

System, Test, Low Density, Lipoprotein

Pointe Scientific, Inc.

Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only. 1 x 240ml, 1 x 80ml

System, Test, Low Density, Lipoprotein

Advia® Chemistry Direct LDL Cholesterol Reagents

LDL Cholesterol - ADVIA Chem. - RGT - 4x188 tests

System, Test, Low Density, Lipoprotein

Pointe autoLDL Cholesterol Reagent

Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BS480. 4 x 60ml R1, 4 x 20ml R2. For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C)…

System, Test, Low Density, Lipoprotein

Carolina Liquid Chemistries Corp.® LDL Cholesterol Direct Reagent KIT DT661

LDL Cholesterol Direct (LDLD) w/ Calibrator

System, Test, Low Density, Lipoprotein

Biobase

19 catalogue numbers from R1:18mL×4 R2:6mL×4, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under System, Test, Low Density, Lipoprotein. 3 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