Enzymatic Esterase–Oxidase, Cholesterol

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Zhejiang, Guangdong and Guangxi, and 3 other provinces: 9 hold an FDA registration. 2 are contract manufacturers.

Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Biobase Biodustry(Shandong)Co., Ltd. Shandong
Dongguan BAO Kang Dian ZI KE JI Limited Guangdong, contract manufacturer
Eaglenos Sciences, Inc. Jiangsu
Hangzhou Lysun Biotechnology Co., Ltd. Zhejiang
Medicalsystem Biotechnology Co., Ltd. Zhejiang
Shijiazhuang Hipro Biotechnology Co., Ltd. Hebei
Urit Medical Electronic Co., Ltd. Guangxi, contract manufacturer
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

How Is CHH Classified?

Enzymatic Esterase–Oxidase, Cholesterol is FDA product code CHH, Class 1, 21 CFR 862.1175.

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 Has Gone Wrong With It?

The FDA has recorded 23 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Device Design (5), Nonconforming Material/Component (2) and Process control (2).

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

Enzymatic Esterase--Oxidase, Cholesterol

Spotchem™ II Total Cholesterol

Strip description for the invitro quantitative determination of total cholesterol in human plasma from whole blood samples

Enzymatic Esterase--Oxidase, Cholesterol

PTS Panels® Chol+hdl+glu Test Strips (10-Ct)

Catalogue number 2469, listed by Polymer Technology Systems, United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Pointe Cholesterol on BS480

Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in serum. For in vitro diagnostic use.

Enzymatic Esterase--Oxidase, Cholesterol

Dimension® Flex® Reagent Cartridge Chol

Cholesterol Flex® reagent cartridge, 480 tests

Enzymatic Esterase--Oxidase, Cholesterol

IDG/Sanzay

For the quantitative determination of total cholesterol in serum

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol Standard (200 Mg/dl)

Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma.

Enzymatic Esterase--Oxidase, Cholesterol

Architect

Catalogue number 7D62-22, listed by Abbott Medical, United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Pointe Scientific Cholesterol Standard

Intended for use as an cholesterol standard for standardization or calibration of enzymatic, endpoint cholesterol procedures.

Enzymatic Esterase--Oxidase, Cholesterol

Synchron

Cholesterol Reagent (CHOL 2 x 300)

Enzymatic Esterase--Oxidase, Cholesterol

CardioChek Plus Home Self-Test Analyzer

The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home…

Enzymatic Esterase--Oxidase, Cholesterol

Chol Reagent Kit

Cholesterol Reagent Kit for use with EasyRA Analyzers

Enzymatic Esterase--Oxidase, Cholesterol

Curo L5 Meter

Catalogue number ILM-0001A, listed by Osang Healthcare Co., Ltd., South Korea, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

CardioChek® Analyzer; Refurbished

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.

Enzymatic Esterase--Oxidase, Cholesterol

Sirrus® Total Cholesterol LiquiColor®

For the Quantitative Colorimetric Determination of Total Cholesterol in Serum and Plasma.

Enzymatic Esterase--Oxidase, Cholesterol

Architect

Cholesterol2 1000 Tests

Enzymatic Esterase--Oxidase, Cholesterol

Mission Cholesterol Test Device – 3-in-1 Lipid Panel 5t

Cholesterol lipid panel test device - 5T

Enzymatic Esterase--Oxidase, Cholesterol

Architect

Catalogue number 7D62-21, listed by Abbott Laboratories, United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

ABX Pentra Cholesterol CP

Catalogue number 1220001634, listed by Horiba ABX SAS, France, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol

Catalogue number 12-C7510-160, listed by Horiba Instruments Incorporated, United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

ChekMate™ Strips

ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.

Enzymatic Esterase--Oxidase, Cholesterol

PTS Panels® Chol+hdl+glu Test Strips (10-Ct) + MeMoChip

Catalogue number 2477, listed by Polymer Technology Systems, United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Chemcard Cholesterol

The CHEMCARD™ Cholesterol Test provides a preliminary semi-quantitative analytical test result that can be used to identify elevated blood cholesterol levels associated with increased risk…

Enzymatic Esterase--Oxidase, Cholesterol

Spotchem™ II HDL-Cholesterol

Strip description for the invitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples

Enzymatic Esterase--Oxidase, Cholesterol

CardioChek

CardioChek Plus Analyzer

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol LiquiColor®

For the Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma.

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol-SL

2 catalogue numbers from 234-60, listed by Sekisui Diagnostics, LLC, United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

HeartsCare C1 Monitoring System

Catalogue number TD-4289, listed by Hearts Bio, Inc., under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Dimension Vista® Flex® Reagent Cartridge Chol

Cholesterol Flex® reagent cartridge, 600 tests

Enzymatic Esterase--Oxidase, Cholesterol

HeartsCare C1 Total Cholesterol Test Strip (10pcs/box)

Catalogue number TD-4289, listed by Hearts Bio, Inc., under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Teco Diagnostics Cholesterol TC-Matrix-240

Teco Diagnostics Cholesterol TC-Matrix-240 is used for the quantitative determination of cholesterol in serum or plasma on TC Matrix analyzers.

Enzymatic Esterase--Oxidase, Cholesterol

Alinity

Cholesterol2 3200 Tests

Enzymatic Esterase--Oxidase, Cholesterol

Xper Technology Procheck Witty Procheck Smart Total Cholesterol Test Strips

Catalogue number TD-4642, listed by Taidoc Technology Corporation, Taiwan, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Spotchem™ II Triglycerides

Strip is for invitro quantitative determination of triglycerides in human plasma from whole blood samples

Enzymatic Esterase--Oxidase, Cholesterol

PTS Panels® Cholesterol Test Strips

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

Enzymatic Esterase--Oxidase, Cholesterol

Accutrend Plus Cholesterol Strips

Catalogue number 05213312160, listed by Roche Diagnostics Gmbh, Germany, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Curo L7 Lipid Test Strip – Lipid Profile

Catalogue number 99LS10-2, listed by SD Biosensor, Inc., South Korea, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Alere Cholestech LDX®

Alere Cholestech LDX® TC GLU

Enzymatic Esterase--Oxidase, Cholesterol

Pointe Cholesterol Reagent

Pointe Cholesterol Reagent packaged for use on the Mindray BA800. 8 x 65ml. For the quantitative determination of Total Cholesterol in serum.

Enzymatic Esterase--Oxidase, Cholesterol

Advia® Chemistry CHOL_c Cholesterol Reagents, Concentrated

Cholesterol - ADVIA Chem. - Conc. RGT - 4x2100/4x1340 tests

Enzymatic Esterase--Oxidase, Cholesterol

Yumizen C1200 Cholesterol

Catalogue number 1300023838, listed by Horiba ABX SAS, France, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Advia® Chemistry CHOL_2 Cholesterol_2 Reagent

Cholesterol - ADVIA Chem. - RGT - 7x350/7x280 tests

Enzymatic Esterase--Oxidase, Cholesterol

Teco Diagnostics Cholesterol Reagent Set

Teco Diagnostics Cholesterol Reagent Set is used for the quantitative determination of total cholesterol in human serum.

Enzymatic Esterase--Oxidase, Cholesterol

Teco Diagnostics Cholesterol TC-Matrix-480

Teco Diagnostics Cholesterol TC-Matrix-480 is used for the quantitative determination of cholesterol in serum or plasma on TC Matrix analyzers.

Enzymatic Esterase--Oxidase, Cholesterol

Carolina Liquid Chemistries Corp.® Cholesterol Reagent KIT BL211

Cholesterol (CHOL) Reagent

Enzymatic Esterase--Oxidase, Cholesterol

JAS Diagnostics

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

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol

PTS Panels® cholesterol self-test strips are for the quantitative measurement of total cholesterol in capillary whole blood from the fingertip. Cholesterol measurements are used in the…

Enzymatic Esterase--Oxidase, Cholesterol

Spotchem™ II Lipid Panel

Strip description for the invitro quantitative determination of HDL-cholesterol, total cholesterol, and triglyceride in human plasma from whole blood samples

Enzymatic Esterase--Oxidase, Cholesterol

Biobase

4 catalogue numbers from R1:20mL×1 R2:5mL×1, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

PTS Panels® CHOL+Glu Test Strips

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

Enzymatic Esterase--Oxidase, Cholesterol

Pointe Scientific, Inc.

Reagent intended for use as an cholesterol standard for standardization or calibration of enzymatic, endpoint cholesterol procedures. 1 x 200 mg/dl

Enzymatic Esterase--Oxidase, Cholesterol

Blood Lipid Test Strip

Catalogue number PFS 30,10strips/vial×2/box, listed by Urit Medical Electronic Co., Ltd., China, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Blood Lipid Analyzer

2 catalogue numbers from PFS-30,1 Set/box, listed by Urit Medical Electronic Co., Ltd., China, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

AimStrip Tandem Total Cholesterol Test Strips

Total Cholestesol test strip

Enzymatic Esterase--Oxidase, Cholesterol

LipidPlus® Total Cholesterol Test Strips

Catalogue number MD532, listed by Jant Pharmacal Corp., United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol

Catalogue number 08057443190, listed by Roche Diagnostics Gmbh, Germany, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Teco Diagnostics Cholesterol (Liquid) Reagent Set

Teco Diagnostics Cholesterol (Liquid) Reagent Set is used for the quantitative determination of total cholesterol in serum.

Enzymatic Esterase--Oxidase, Cholesterol

Pointe Scientific Cholesterol (Liquid)

3 catalogue numbers from C7510-500, listed by Horiba Instruments Incorporated, United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Atellica CH Chol_2

Cholesterol (Chol-2) Atellica CH - RGT 8400T

Enzymatic Esterase--Oxidase, Cholesterol

ACE

Cholesterol Reagent

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol Reagent

Catalogue number 500mL, listed by Clinical Diagnostic Solutions, Inc., United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol (Chol)

For the quantitative in vitro determination of cholesterol in serum and plasma.

Enzymatic Esterase--Oxidase, Cholesterol

Standard™ LipidoCare Lipid Test Strip – Lipid Profile

4 catalogue numbers from 02LS10C, listed by SD Biosensor, Inc., South Korea, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Curo L5 TC Test Strip

Catalogue number ILM-0001A, listed by Osang Healthcare Co., Ltd., South Korea, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol

Catalogue number SK234-10, listed by Sekisui Diagnostics, LLC, United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Standard™ LipidoCare Analyzer

2 catalogue numbers from 02LA20G, listed by SD Biosensor, Inc., South Korea, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Chol

For the quantitative in vitro determination of cholesterol in serum and plasma.

Enzymatic Esterase--Oxidase, Cholesterol

Alinity

Alinity c Cholesterol Reagent Kit

Enzymatic Esterase--Oxidase, Cholesterol

Carolina Liquid Chemistries Corp.® Chol Cholesterol Reagent CC211

CHOL (Cholesterol) 2 x 300 tests

Enzymatic Esterase--Oxidase, Cholesterol

Cholestech LDX™

Cholestech LDX™ TC GLU

Enzymatic Esterase--Oxidase, Cholesterol

Newfoundland Cholesterol Test

Catalogue number 6450, listed by DFI Co., Ltd., South Korea, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Teco Diagnostics Cholesterol TC Matrix

Teco Diagnostics Cholesterol TC Matrix is used for the quantitative determination of cholesterol in serum or plasma on TC Matrix analyzers.

Enzymatic Esterase--Oxidase, Cholesterol

Fora

Total Cholesterol Test System

Enzymatic Esterase--Oxidase, Cholesterol

Heartscare Total Cholesterol Test Strip (10pcs/box)

Catalogue number TD-4289, listed by Hearts Bio, Inc., under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Pointe Scientific, Inc. Cholesterol

Pointe Scientific, Inc. Cholesterol is for the quantitative determination of Total Cholesterol in serum on Olympus analyzers. 12 x 65ml

Enzymatic Esterase--Oxidase, Cholesterol

AU

3 catalogue numbers from OSR6116, listed by Beckman Coulter, Inc., United States, under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

ClearChem Diagnostics Inc. Cholesterol, Total

Catalogue number CHL1100, listed by Clearchem Diagnostics Inc., under Enzymatic Esterase--Oxidase, Cholesterol. 9 manufacturers in China are registered for this product code.

Enzymatic Esterase--Oxidase, Cholesterol

Synermed®

Cholesterol Reagent 1 X 250 mL + 1 X 100 mL

Enzymatic Esterase--Oxidase, Cholesterol

Cholesterol Gen.2

3 catalogue numbers from 05168538190, listed by Roche Diagnostics Gmbh, Germany, under Enzymatic Esterase--Oxidase, Cholesterol. 9 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