Nadh Oxidation/Nad Reduction, Ast/Sgot

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Jilin and Shandong.

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

How Is CIT Classified?

Nadh Oxidation/Nad Reduction, Ast/Sgot is FDA product code CIT, Class 2, 21 CFR 862.1100.

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 13 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Material/Component Contamination (2), Device Design (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.

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST

Catalogue number SK319-20, listed by Sekisui Diagnostics, LLC, United States, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminotransferase Withwithout Pyridoxal Phosphate Activation

Catalogue number 4657543190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Pointe AST on the BS480 Analyzer

Pointe AST packaged for use on the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Aspartate Aminotransferase (AST) in human serum on the BS480 Analyzer.

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST (Sgot) Reagent Set

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. AST is widely distributed in tissues with the highest concentrations found in the liver, heart,…

Nadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminotransferase Kit (Colorimetric Method)

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

Nadh Oxidation/Nad Reduction, Ast/Sgot

Advia® Chemistry AST(GOT) Reagents

AST/GOT - ADVIA Chem. - RGT - 7x360 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST / BS480

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum using the Mindray BS-480 analyzer. 5 x 60 ml, 5 x 15 ml

Nadh Oxidation/Nad Reduction, Ast/Sgot

Advia® Chemistry (AST_c) AST(GOT) Reagents Concentrated

AST/GOT - ADVIA Chem. - Conc. RGT - 6x850 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

ABX Pentra AST CP

Catalogue number 1220001629, listed by Horiba ABX SAS, France, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Dimension® Flex® Reagent Cartridge AST

Aspartate Aminotransferase Flex® reagent cartridge, 360 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

Sirrus® AST/Sgot Liqui-UV®

For the Kinetic Quantitative Determination of AST/GOT in Serum or Plasma.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Pointe AST Reagent

Pointe AST Reagent packaged for use on the Mindray BA800. 5 x 67ml R1, 5 x 17ml R2. For the quantitative determination of Aspartate Aminotransferase (AST) in human serum.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Carolina Liquid Chemistries Corp.™ AST Reagent CC241

AST (Aspartate Aminotransferase) 2 x 200 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

Carolina Liquid Chemistries Corp.® AST Reagent Product NO. DT241

AST (Aspartate Aminotransferase) 4 x 400 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST-SL

Catalogue number 319-30, listed by Sekisui Diagnostics, LLC, United States, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Advia® Chemistry Aspartate Aminotransferase (AST) Reagents

AST/GOT - ADVIA Chem. - RGT - 6x670 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST (Sgot) Kinetic Method TC MATRIX-240/480

The AST (SGOT) KINETIC METHOD TC MATRIX-240/480 is used for the quantitative determination of aspartate aminotransferase activity in serum or plasma on TC Matrix analyzer.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminotransferase Acc. To Ifcc II

Catalogue number 08104719190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Advia® Chemistry P5P Pyridoxal-5-Phosphate Reagents

Pyridoxal-5-Phosphate Reagents

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST (Sgot) Reagent SET (UV-Kinetic Method)

The AST (SGOT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of Aspartate Aminotransferase (AST) in human serum.

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST / BS200

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

Nadh Oxidation/Nad Reduction, Ast/Sgot

Genchem™ AST/Sgot

Catalogue number GEN-AST R1, listed by Genchem, Inc., United States, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

ACE

AST Reagent

Nadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminotransferase Acc to Ifcc With Pyridoxal Phosphate Activation

2 catalogue numbers from 4467493190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminotransferase Acc to Ifcc Withwithout Pyridoxal Phosphate Activat

3 catalogue numbers from 4571100190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

ClearChem Diagnostics Inc. Aspartate Aminotransferase (AST)

Catalogue number AST1040, listed by Clearchem Diagnostics Inc., under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Synchron

Aspartate Aminotransferase Reagent (AST- 2 x 100)

Nadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminotransferase Acc to Ifcc Without Pyridoxal Phosphate Activation

2 catalogue numbers from 5850819190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Pointe Scientific AST (Sgot) Liquid

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Pointe Scientific, Inc. AST

Pointe Scientific, Inc. AST Reagent is for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged with barcodes for use on AU400, AU480 and AU640. 6 x…

Nadh Oxidation/Nad Reduction, Ast/Sgot

IDG/Sanzay

For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reagents are used in routine examination and monitoring of therapy and relapses.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Thermo Scientific Infinity™

Catalogue number TR70121, listed by Fisher Diagnostics, United States, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Piccolo AmLyte 13

The Piccolo® AmLyte 13 , used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin,…

Nadh Oxidation/Nad Reduction, Ast/Sgot

Architect

Activated Aspartate Aminotransferase

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST/Sgot Liquid Reagent (Kinetic Method)

The AST/SGOT LIQUID REAGENT (KINETIC METHOD) is used for the quantitative determination of aspartate aminotransferase (AST) in human serum. The reagents are used in routine examination and…

Nadh Oxidation/Nad Reduction, Ast/Sgot

Pointe Scientific

AST Reagent Set for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged at 5 x 100ml, 2 x 55ml

Nadh Oxidation/Nad Reduction, Ast/Sgot

Advia Chemistry P5PL_c Reagent

ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST/Sgot Liqui-UV®

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

Nadh Oxidation/Nad Reduction, Ast/Sgot

Carolina Liquid Chemistries Corp.® CLC720 AST RGT KIT Product No. ST241

AST (Aspartate Aminotransferase) 4 x 300 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

Dimension Vista® Flex® Reagent Cartridge AST

Aspartate Aminotransferase Flex® reagent cartridge, 1600 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminosransferase Acc. To Ifcc With Pyridoxal Phosphate Activation

Catalogue number 08056838190, listed by Roche Diagnostics Gmbh, Germany, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Atellica™ CH ASTP5P

Aspartate Aminotransferase P5P (ASTP5P) - Atellica™ CH - RGT - 1684T

Nadh Oxidation/Nad Reduction, Ast/Sgot

Atellica CH ASTPLc

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

Nadh Oxidation/Nad Reduction, Ast/Sgot

Aspartate Aminotransferase (AST)

Catalogue number AS8005, listed by Randox Laboratories Limited, United Kingdom, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 manufacturers in China are registered for this product code.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Piccolo BioChemistry Panel Plus

The Piccolo® BioChemistry Panel Plus, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT),…

Nadh Oxidation/Nad Reduction, Ast/Sgot

Architect

Activated Aspartate Aminotransferase 2750 Tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

Sgot (AST) Reagent Kit

Aspartate Aminotransferase Reagent Kit for use with EasyRA Analyzers

Nadh Oxidation/Nad Reduction, Ast/Sgot

Piccolo General Chemistry 13

The Piccolo® General Chemistry 13 used with the Piccolo blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative…

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST / Polychem 180

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum using the Poly-Chem 180 analyzer. 6 x 50 ml, 3 x 20 ml

Nadh Oxidation/Nad Reduction, Ast/Sgot

Synermed®

AST Reagent 4 X 100 mL + 1 X 100 mL

Nadh Oxidation/Nad Reduction, Ast/Sgot

Pointe Scientific AST

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum.

Nadh Oxidation/Nad Reduction, Ast/Sgot

Carolina Liquid Chemistries Corp.® AST RGT. KIT BL-241

AST (Aspartate Aminotransferase) 3 x 100 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

Pointe Scientific, Inc.

AST Reagent, for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Size:1 x 2L, 1 x 500mL

Nadh Oxidation/Nad Reduction, Ast/Sgot

Alinity

Activated Aspartate Aminotransferase 3500 Tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

Atellica CH AST

Aspartate Aminotransferase (AST) Atellica CH - RGT 2550T

Nadh Oxidation/Nad Reduction, Ast/Sgot

Architect

Activated Aspartate Aminotransferase

Nadh Oxidation/Nad Reduction, Ast/Sgot

Vitros

VITROS Chemistry Products AST Slides

Nadh Oxidation/Nad Reduction, Ast/Sgot

AST

The AST method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of aspartate aminotransferase activity in serum or…

Nadh Oxidation/Nad Reduction, Ast/Sgot

AU

AST

Nadh Oxidation/Nad Reduction, Ast/Sgot

Alinity

Alinity c Activated Aspartate Aminotransferase Reagent Kit 3500 Tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

Carolina Liquid Chemistries Corp.® AST RGT. KIT AU-241

AST (Aspartate Aminotransferase) 3 x 250 tests

Nadh Oxidation/Nad Reduction, Ast/Sgot

JAS Diagnostics

AST LIQUID REAGENT (125mL) Unlabeld Vial

Nadh Oxidation/Nad Reduction, Ast/Sgot

Biobase

19 catalogue numbers from R1:64mL×6 R2:48mL×2, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Nadh Oxidation/Nad Reduction, Ast/Sgot. 2 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