Ldl & Vldl Precipitation, Hdl

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Zhejiang and Guangxi: 3 hold an FDA registration. 1 is a contract manufacturer.

Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Hangzhou Lysun Biotechnology Co., Ltd. Zhejiang
Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer

What Is FDA Product Code LBR?

Ldl & Vldl Precipitation, Hdl is FDA product code LBR, Class 1, 21 CFR 862.1475.

What Does It Take to Sell It in the United States?

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 11 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (3), Process control (2) and Error in labeling (1).

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

Ldl & Vldl Precipitation, Hdl

L-Type LDL-C Reagent 1

Catalogue number 999-00404, listed by Fujifilm Wako Pure Chemical Corporation, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Pointe Scientific, Inc. autoHDL Cholesterol

Pointe Scientific, Inc. autoHDL Cholesterol Reagent is for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only.…

Ldl & Vldl Precipitation, Hdl

HDL Cholesterol Precipitating Reagent

For Use in the Determination of High Density Lipoprotein (HDL) Cholesterol in Serum or Plasma.

Ldl & Vldl Precipitation, Hdl

MedTest DX Auto HDL/LDL Calibrator

auto HDL/LDL Calibrator, For the calibration of autoHDL™ and autoLDL™ Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only. Size: 3 x 40mL, 3 x 14mL

Ldl & Vldl Precipitation, Hdl

IDG/Sanzay

The IDG HDL-Cholesterol reagent 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, Hdl

CardioChek® Plus Professional Analyzer

Catalogue number 2700, listed by Polymer Technology Systems, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Alinity

Alinity c Direct LDL Reagent Kit

Ldl & Vldl Precipitation, Hdl

autoHDL

For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only.

Ldl & Vldl Precipitation, Hdl

PTS Panels® Chol+hdl Test Strips

PTS Panels® CHOL+HDL test strips are in vitro diagnostic devices used to monitor HDL cholesterol and total cholesterol levels in human whole blood. These test strips must be used in…

Ldl & Vldl Precipitation, Hdl

L-Type LDL-C Reagent 2

Catalogue number 999-00504, listed by Fujifilm Wako Pure Chemical Corporation, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Pointe autoHDL Cholesterol Reagent

Pointe autoHDL Cholesterol Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 20ml R2. For the quantitative determination high-density lipoprotein cholesterol in human serum or…

Ldl & Vldl Precipitation, Hdl

L-Type HDL-C Reagent 1

2 catalogue numbers from 997-72591, listed by Fujifilm Wako Pure Chemical Corporation, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Pointe autoHDL for the BS480

Pointe autoHDL Reagent packaged for use on the BS480 Analyzer. 4x57mL, 4x18mL Kit. For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in…

Ldl & Vldl Precipitation, Hdl

ABX Pentra LDL Direct CP

Catalogue number 1220001638, listed by Horiba ABX SAS, France, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Assy Vial, Lipid Panel Test Strips, 15 Ct, CardioChek Plus Home

Catalogue number REF 4747, listed by Polymer Technology Systems, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Mission Cholesterol Test Device – 3-in-1 Lipid Panel 25t

Choleterol lipid panel test device - 25T

Ldl & Vldl Precipitation, Hdl

CardioChek Plus Home Lipid Panel Self-Test Strip 2ct

Catalogue number 4722, listed by Polymer Technology Systems, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Carolina Liquid Chemistries Corp.® Hdld RGT. KIT AU-616

HDLD (High Density Lipoprotein Direct) w/ cal 3 x 250 tests

Ldl & Vldl Precipitation, Hdl

CardioChek

CardioChek 15Lipid/15Glucose

Ldl & Vldl Precipitation, Hdl

Mission Cholesterol Control Solution

Cholesterol control solution

Ldl & Vldl Precipitation, Hdl

HDL-Cholesterol (HDL)

Catalogue number CH203, listed by Randox Laboratories Limited, United Kingdom, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

MedTest DX autoHD™L / BS480

AutoHDL™, For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BS-480 analyzer. For in vitro diagnostic use only. Size: 4 x 57…

Ldl & Vldl Precipitation, Hdl

LDL Direct LS Cholesterol Reagent Kit

Catalogue number 7120, listed by Sekisui Diagnostics, LLC, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Vitros

VITROS Chemistry Products CHOL Slides

Ldl & Vldl Precipitation, Hdl

ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol

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

Ldl & Vldl Precipitation, Hdl

CardioChek® Analyzer

The CardioChek® Analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.

Ldl & Vldl Precipitation, Hdl

Teco Diagnostics HDL Cholesterol Reagent Set

Teco Diagnostics HDL Cholesterol Reagent Set is used for the quantitative determination of high density lipoprotein (HDL) in human serum.

Ldl & Vldl Precipitation, Hdl

Synermed®

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

Ldl & Vldl Precipitation, Hdl

ABX Pentra HDL Direct 100 CP

Catalogue number 1220001934, listed by Horiba ABX SAS, France, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

PTS Panels® HDL Cholesterol Test Strips

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

Ldl & Vldl Precipitation, Hdl

ABX Pentra HDL Direct CP

Catalogue number 1220001636, listed by Horiba ABX SAS, France, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Carolina Liquid Chemistries Corp.® LDL Direct Reagent CC667

LDLD (LDL Cholesterol Direct) w/ cal 2 x 200 tests

Ldl & Vldl Precipitation, Hdl

N-Geneous LDL Cholesterol Reagent (R2)

2 catalogue numbers from 80-4601-00, listed by Sekisui Diagnostics, LLC, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

LDL Cholesterol Reagent Set

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

Ldl & Vldl Precipitation, Hdl

N-Geneous LDL Cholesterol Reagent (R1)

2 catalogue numbers from 80-4598-00, listed by Sekisui Diagnostics, LLC, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

MedTest DX autoHDL / BS200

HDL600, for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BS-200 analyzer. For in vitro diagnostic use only. Size: 3 x 51…

Ldl & Vldl Precipitation, Hdl

LDL-Cholesterol Gen.3

3 catalogue numbers from 07005768190, listed by Roche Diagnostics Gmbh, Germany, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Pointe Scientific

HDL reagent for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. 6 x 60ml, 6 x 20ml

Ldl & Vldl Precipitation, Hdl

Pointe Scientific, Inc.

HDL Cholesterol Standard, for use as a cholesterol standard for standardization or calibration of enzymatic, endpoint cholesterol assays used with HDL Cholesterol procedures. Size: 1 x 15…

Ldl & Vldl Precipitation, Hdl

Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix

Teco Diagnostics Direct HDL Cholesterol Reagent Set is used for the quantitative determination of high-density lipoprotein (HDL) in human serum or plasma on an automated analyzer. For in…

Ldl & Vldl Precipitation, Hdl

MedTest DX autoHDL for PC180

For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Polychem 180 analyzer. For in vitro diagnostic use only. 3 x 51 ml, 2 x 20 ml

Ldl & Vldl Precipitation, Hdl

L-Type HDL-C Reagent 2

2 catalogue numbers from 993-72691, listed by Fujifilm Wako Pure Chemical Corporation, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Yumizen C1200 LDL Direct

Catalogue number 1300023857, listed by Horiba ABX SAS, France, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Yumizen C1200 HDL Direct

Catalogue number 1300023852, listed by Horiba ABX SAS, France, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

CardioChek® Plus Professional Analyzer, Refurbished

Catalogue number 2702, listed by Polymer Technology Systems, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Assy Vial, Lipid Panel Test Strips, 1 Ct, CardioChek Plus Home

Catalogue number REF 4749, listed by Polymer Technology Systems, United States, under Ldl & Vldl Precipitation, Hdl. 3 manufacturers in China are registered for this product code.

Ldl & Vldl Precipitation, Hdl

Curo L5

CURO L5 Glucose Strip

Ldl & Vldl Precipitation, Hdl

Carolina Liquid Chemistries Corp.® CLC720 HDL RGT KIT Product No. ST616

HDLD (HDL Cholesterol Direct) w/ cal 2 x 250 tests

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