Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Who Makes This Device Type in China?

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

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Dirui Industrial Co., Ltd. Jilin, contract manufacturer

What Is FDA Product Code CFJ?

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase is FDA product code CFJ, Class 2, 21 CFR 862.1440.

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 8 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (1), Equipment maintenance (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.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Dimension Vista® Flex® Reagent Cartridge LDI

Lactate Dehydrogenase Flex® reagent cartridge, 800 Tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

ACE

LDH-L Reagent

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Advia® Chemistry Ldpl Reagents

LDH P->L - ADVIA Chem. - RGT - 5x358 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method)

Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method): 1 catalogue number listed by Medicalsystem Biotechnology Co., Ltd., China, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Vitros

VITROS Chemistry Products LDHI Slides

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Dimension® LDI Flex® Reagent Cartridge

Lactate Dehydrogenase Flex® reagent cartridge, 480 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LDH-L

For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Atellica CH Lac

Lactate (Lac) Atellica CH - RGT 380T

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Pointe Lactate Reagent

Pointe Lactate Reagent Kit packaged for use on the Mindray BS480; 4 x 57ml R1, 4 x 38ml R2; For the quantitative determination of lactate in human plasma. For in vitro diagnostic use only.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

ClearChem Diagnostics Inc. Lactate Dehydogenase (LDH)

Catalogue number LDH1170, listed by Clearchem Diagnostics Inc., under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Lactate Dehydrogenase Kit (Kinetic Method)

Lactate Dehydrogenase Kit (Kinetic Method): 1 catalogue number listed by Medicalsystem Biotechnology Co., Ltd., China, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LDH Reagent Set

For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum…

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Pointe Scientific, Inc. LD

Pointe Lactate Dehydrogenase Reagent is for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only. 1 x 1L,…

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Carolina Liquid Chemistries Corp.® LDH RGT. KIT AU-205

LDH (Lactate Dehydrogenase) 3 x 300 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LDH

The LDH method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of lactate dehydrogenase activity in serum or…

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Carolina Liquid Chemistries Corp.™ LD-L Reagent CC205

LDH (Lactate Dehydrogenase) 2 x 200 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Lactate Dehrydrogenase-SL Assay

Catalogue number 327-30, listed by Sekisui Diagnostics, LLC, United States, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Teco Diagnostics LDH-L Reagent Set

Teco Diagnostics LDH-L Reagent Set is for the quantitative determination of lactate dehydrogenase activity in human serum.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Yumizen C1200 LDH

Catalogue number 1300023855, listed by Horiba ABX SAS, France, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Advia® Chemistry Lactate Dehydrogenase P-L (Ldpl) Reagents

LDH P->L - ADVIA Chem. - RGT - 6x670 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Advia® Chemistry Ldlp Lactate Dehydrogenase Reagents

LDH L->P - ADVIA Chem. - RGT - 6x670 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Advia® Chemistry Ldlp Reagents

LDH L->P - ADVIA Chem. - RGT - 7x274 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Lactate Dehydrogenase Acc to Ifcc Ver2

2 catalogue numbers from 3004732122, listed by Roche Diagnostics Gmbh, Germany, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Teco Diagnostics Lactate Dehydrogenase (LDH-L) Liquid Reagent Set

Teco Diagnostics Lactate Dehydrogenase (LDH-L) Liquid Reagent Set is for the In Vitro quantitative kinetic determination of Lactate Dehydrogenase activity in serum.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Carolina Liquid Chemistries Corp.® CLC720 LDH RGT KIT Product No. ST205

LDH (Lactate Dehydrogenase) 4 x 250 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LDH Liqui-UV®

For the Quantitative Determination of Lactate Dehydrogenase in Serum and EDTA Plasma.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Atellica CH Ldlp

Lactate Dehydrogenase (LDLP) Atellica CH - RGT 1792T

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Architect

Lactate Dehydrogenase2

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Pointe Lactate Dehydrogenase Reagent

Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BA800. 4 x 42ml R1, 4 x 17ml R2. For the quantitative kinetic determination of lactate dehydrogenase activity in serum.…

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

MedTest DX Lactate Dehydrogenase / BS480

Lactate Dehydrogenase, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-480 analyzer. Size: 4 x 40 ml, 4 x 10 ml.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Alinity

Alinity c Lactate Dehydrogenase Reagent Kit 1960 Tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Sirrus® LDH Liqui-UV®

For the Quantitative Determination of Lactate Dehydrogenase in Serum.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Synchron

Lactate Dehydrogenase Reagent (LD-P 2 x 200)

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LD Opt. (LDH P-L)

2 catalogue numbers from LD8051, listed by Randox Laboratories Limited, United Kingdom, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

AU

2 catalogue numbers from OSR6127, listed by Beckman Coulter, Inc., United States, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

MedTest DX Lactate Standard

Lactate Standard, intended for use as an Lactate standard for standardization or calibration of Lactate Oxidase, Lactate procedures. Size: 1 x15 ml

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Advia® Chemistry LAC Lactate Reagents

Lactate - ADVIA Chem. - RGT - 3x100 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Carolina Liquid Chemistries Corp.® LDH Reagent Product NO. DT205

LDH (Lactate Dehydrogenase) 4 x 300 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Lactate Dehydrogenase Liquid Acc to Ifcc

3 catalogue numbers from 4794940190, listed by Roche Diagnostics Gmbh, Germany, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Architect

2 catalogue numbers from 2P56-22, listed by Abbott Medical, United States, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

MedTest Dx, Inc. Lactate Dehydrogenase

Reagent for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-200 analyzer. 2 x 40 ml, 2 x 10 ml

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LDH P-L

A lactate dehydrogenase test system is a device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum or plasma.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Lactate Dehydrogenase Acc. To Ifcc Ver.2

2 catalogue numbers from 08057958190, listed by Roche Diagnostics Gmbh, Germany, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Pointe Lactic Acid Reagent

Pointe Lactic Acid Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 40ml R2. For the quantitative determination of lactate in human plasma. For in vitro diagnostic use only.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Pointe Scientific, Inc.

Lactate Dehydrogenase Reagent, for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 4 x 100mL,…

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Pointe Scientific, Inc. Lactate

Pointe Scientific, Inc. Lactate Reagent is for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Olympus analyzers. For in vitro diagnostic use only. 5 x…

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LD Opt. (LDH L-P)

Catalogue number LD8052, listed by Randox Laboratories Limited, United Kingdom, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

ABX Pentra LDH Ifcc CP

Catalogue number 1220001871, listed by Horiba ABX SAS, France, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Thermo Scientific

Catalogue number TR20015, listed by Fisher Diagnostics, United States, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix

Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix is for the quantitative determination of lactate dehydrogenase activity in serum or plasma on TC Matrix analyzers.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Lactate Dehydrogenase Assay

Catalogue number SK327-20, listed by Sekisui Diagnostics, LLC, United States, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Synermed®

LDH Reagent 3 X 250 mL + 3 X 100 mL

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Carolina Liquid Chemistries Corp.® LDH RGT. KIT BL-205

LDH (Lactate Dehydrogenase) 3 x 100 tests

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

LDH L-P

A lactate dehydrogenase test system is a device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum or plasma.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Piccolo Basic Metabolic Panel Plus

The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative…

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Architect

Catalogue number 2P56-21, listed by Abbott Laboratories, United States, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Biobase

13 catalogue numbers from R1:48mL×2 R2:24mL×1, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase. 2 manufacturers in China are registered for this product code.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

IDG/Sanzay

Lactate Dehydrogenase LS (LDH-L) liquid reagent is intended to use for the In Vitro quantitative kinetic determination of Lactate Dehydrogenase activity in serum.

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

MedTest DX Lactate

Lactate, for the quantitative determination of lactate in human plasma on the Mindray BS-480 Analyzer. For in vitro diagnostic use only. Size: 4 x 57 ml, 4 x 38 ml

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Alinity

Lactate Dehydrogenase2

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

JAS Diagnostics

LDH LIQUID (1x 120mL R1, 1x 30mL R2)

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