Nadh Oxidation/Nad Reduction, Alt/Sgpt

Which Manufacturers in China Make This?

3 manufacturers in China hold an FDA registration for this device type, concentrated in Jilin, Shandong and Zhejiang.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

What Is FDA Product Code CKA?

Nadh Oxidation/Nad Reduction, Alt/Sgpt is FDA product code CKA, Class 1, 21 CFR 862.1030.

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 18 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Process control (9), Device Design (3) and Process change control (1).

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

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT / BS200

For the quantitative determination of Alanine Aminotransferase (ALT) in serum using the Mindray BS-200 analyzer. 2 x 40 ml, 2 x 10 ml

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ABX Pentra ALT CP

Catalogue number 1220001627, listed by Horiba ABX SAS, France, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

IDG/Sanzay

For the quantitative determination of alanine aminotransferase in serum used in routine examination and monitoring of therapy and relapses.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Sirrus® ALT/Sgpt Liqui-UV®

For the Kinetic Quantitative Determination of ALT/GPT in Serum and Plasma.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Dimension® Dimension Vista® System Enzyme Diluent

Enzyme Diluent, 10x10mL

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Dimension® Flex® Reagent Cartridge Alti

Alanine Aminotransferase Flex® reagent cartridge, 240 tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

AU

ALT

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Carolina Liquid Chemistries Corp.® Phosphorus Reagent KIT BL218

Alkaline Aminotransferase (ALT) (GPT) Reagent

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Atellica CH ALTPLc

Alanine Aminotransferase Liquid (ALTPLc) Atellica CH - RGT 2080T

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT

Catalogue number SK318-20, listed by Sekisui Diagnostics, LLC, United States, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ClearChem Diagnostics Inc. Alanine Aminotransferase (ALT)

Catalogue number ALT1020, listed by Clearchem Diagnostics Inc., under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Advia® Chemistry Alanine Aminotransferase ALT Reagents

ALT/GPT - ADVIA Chem. - RGT - 6x670 tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT / BS480

For the quantitative determination of alkaline phosphatase in human serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device. 5 x 60 ml, 5 x 15 ml.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Vitros

VITROS XT Chemistry Products ALTV-AST Slides

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pointe Scientific ALT

Catalogue number 12-A7526-100, listed by Horiba Instruments Incorporated, United States, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Atellica CH ALT

Alanine Aminotransferase (ALT) Atellica CH - RGT 2550T

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Architect

Activated Alanine Aminotransferase

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT R1 (W/ssa#)

2 catalogue numbers from 13-A7526-R1-500, listed by Horiba Instruments Incorporated, United States, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pointe Scientific, Inc.

ALT Reagent, for the quantitative determination of Alanine Aminotransferase in serum. Size: 1 x 2L, 1 x 500mL

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Alanine Aminotransferase Acc. To Ifcc With Pyridoxal Phosphate Activation

2 catalogue numbers from 08056773190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Carolina Liquid Chemistries Corp.® Alkaline Aminotransferase Reagent AU-240

Alkaline Aminotransferase (ALT) (GPT) Reagent

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Alanine Aminotransferase Acc. To Ifcc II

Catalogue number 08104697190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Alanine Aminotransferase / Aspartate Aminotransferase Acc. To Ifcc With PYP

Catalogue number 5531462190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pointe Scientific

ALT reagent for the quantitative determination of alanine aminotransferase in serum on Hitachi analyzers. For in vitro diagnostic use only. 6 x 67ml, 6 x 17ml

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Yumizen C1200 AST

Catalogue number 1300023832, listed by Horiba ABX SAS, France, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Atellica CH ALTP5P

Alanine Aminotransferase P5P (ALTP5P) Atellica CH - RGT 1684T

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT (Sgpt) Liquid Reagent (Kinetic Method)

The ALT(SGPT) Liquid Reagent (Kinetic Method) is used for the quantitative determination of alanine aminotransferase in serum used in routine examination and monitoring of therapy and…

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pointe Scientific, Inc. ALT

Pointe Scientific, Inc. ALT Reagent is for the quantitative determination of Alanine Aminotransferase in serum. Packaged with barcodes for use on AU400, AU480 and AU640. 6 x 67ml, 5 x 17ml.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT (Sgpt) Reagent Set

For the quantitative determination of Alanine Aminotransferase in serum. ALT is widely distributed in tissues with the highest concentrations found in the liver and kidneys. Even so, ALT is…

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Advia® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents

ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Yumizen C1200 ALT

Catalogue number 1300023797, listed by Horiba ABX SAS, France, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pointe Scientific ALT (Sgpt) Liquid

3 catalogue numbers from A7526-625, listed by Horiba Instruments Incorporated, United States, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT Reagent

For the quantitative in vitro determination of Alanine Aminotransferase (ALT) in serum and plasma. 6 x 51 ml, 6 x 14 ml

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Synermed®

ALT Reagent 4 X 100 mL + 1 X 100 mL

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Advia® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated

ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Architect

Activated Alanine Aminotransferase 4820 Tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Alinity

Alinity c Activated Alanine Aminotransferase Reagent Kit 3000 Tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Alanine Aminotransferase Acc. Ifcc With or Without PYP

Catalogue number 4718569190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Synchron

Alanine Aminotransferase Reagent (ALT- 2 x 300)

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Alinity

Activated Alanine Aminotransferase 3000 Tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT/Sgpt Liqui-UV®

For the Kinetic Quantitative Determination of ALT/ GPT in Serum for Manual and/or Automated Procedures.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT (Sgpt) Reagent SET (UV-Kinetic Method)

The ALT (SGPT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of alanine aminotransferase in human serum.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ACE

ALT Reagent

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Architect

Activated Alanine Aminotransferase

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Carolina Liquid Chemistries Corp.® Alanine Aminotransferase Reagent KIT ST240

Alanine Aminotransferase (ALT) (GPT) Reagent

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT-SL Assay

Catalogue number 318-30, listed by Sekisui Diagnostics, LLC, United States, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pointe Scientfic Inc.

ALT Reagent Set for the quantitative determination of alanine aminotransferase in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 5 x 100ml, 2 x 55ml

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Dimension Vista® Flex® Reagent Cartridge Alti

Alanine Aminotransferase Flex® reagent cartridge, 480 tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pointe ALT for the BS480

Pointe ALT packaged for the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Alanine Aminotransferase in serum on the BS480 Analyzer.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT R2 (W/ssa#)

Catalogue number 13-A7526-R2-125, listed by Horiba Instruments Incorporated, United States, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT

An ALT test system is a device intended for the quantitative in vitro determination of of Alanine Aminotransferase (ALT) activity in serum and plasma.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Alanine Aminotransferase Acc. To Ifcc Without Pyridoxal Phosphate Activation

2 catalogue numbers from 20764957322, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

JAS Diagnostics

ALT PALS BULK (in 20 dry Liter bottles)

Nadh Oxidation/Nad Reduction, Alt/Sgpt

ALT (Sgpt) Kinetic Method TC MATRIX-240/480

The ALT (SGPT) KINETIC METHOD TC MATRIX-240/480 is used for the quantitative determination of alanine aminotransferase in serum used in routine examination and monitoring of therapy and…

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Advia® Chemistry ALT(GPT) Reagents

ALT/GPT - ADVIA Chem. - RGT - 7x360 tests

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Biobase

18 catalogue numbers from R1:50mL×2 R2:25mL×1, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Alanine Aminotransferase (ALT)

10 catalogue numbers from AL8006, listed by Randox Laboratories Limited, United Kingdom, under Nadh Oxidation/Nad Reduction, Alt/Sgpt. 3 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Pointe ALT Reagent

Pointe ALT Reagent packaged for use on the Mindray BA800. 5 x 67ml R1, 5 x 17ml R2. For the quantitative determination of Alanine Aminotransferase in serum.

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