Hexokinase, Glucose

Who Makes This Device Type in China?

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

Roche Diagnostics (Suzhou) Ltd. Jiangsu
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Guangdong

What Is FDA Product Code CFR?

Hexokinase, Glucose is FDA product code CFR, Class 2, 21 CFR 862.1345.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 22 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Process control (6), Device Design (3) and Process design (1).

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

Hexokinase, Glucose

Glucose Reagent

For the in vitro quantitative measurement of glucose in serum. The measurement of glucose concentrations in biological fluids has been well documented. Glucose testing can be diagnostically…

Hexokinase, Glucose

Dimension Vista® Flex® Reagent Cartridge GLU

Glucose Flex® reagent cartridge, 480 tests

Hexokinase, Glucose

Carolina Liquid Chemistries Corp.® GLU RGT. KIT BL-208

GLU (Glucose) 3 x 110 tests

Hexokinase, Glucose

Glucose Liqui-UV®

For the Quantitative Determination of Glucose in Serum or Plasma.

Hexokinase, Glucose

Glucose HK Gen3

Catalogue number 5168791190, listed by Roche Diagnostics Gmbh, Germany, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Thermo Scientific Infinity™

Catalogue number TR15421, listed by Fisher Diagnostics, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Carolina Liquid Chemistries Corp.® GLU Reagent Product NO. DT208

GLU (Glucose) 4 x 300 tests

Hexokinase, Glucose

Glucose UV Reagent

Catalogue number R85411, listed by Cliniqa Corporation, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

AU

3 catalogue numbers from OSR6221, listed by Beckman Coulter, Inc., United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Pointe Glucose Hexokinase for BS480

Pointe Glucose Hexokinase Reagent packaged for use on the BS480. 8x60 mL Kit. For the in vitro quantitative measurement of glucose in serum.

Hexokinase, Glucose

Architect

2 catalogue numbers from 3L82-22, listed by Abbott Medical, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Pointe Scientific, Inc.

Reagent for the in vitro quantitative measurement of glucose in serum. 1 x 500ml

Hexokinase, Glucose

IDG/Sanzay

For the In Vitro quantitative determination of glucose in human serum or plasma.

Hexokinase, Glucose

Glucose HK

3 catalogue numbers from 08057800190, listed by Roche Diagnostics Gmbh, Germany, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Sirrus® Glucose Liqui-UV®

For the Quantitative Determination of Glucose in Serum, Plasma, CSF or Urine.

Hexokinase, Glucose

ACE

Glucose Reagent

Hexokinase, Glucose

Carolina Liquid Chemistries Corp.® GLU Glucose Reagent CC208

GLU (Glucose) 2 x 300 tests

Hexokinase, Glucose

Synchron

Synchron Glucose 2 x 300 GLUH Reagent

Hexokinase, Glucose

Glucose HK Gen. 3

Catalogue number 05168791214, listed by Roche Diagnostics Gmbh, Germany, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Glucose (HK)

For in vitro diagnostic use in the quantitative determination of the glucose concentration in human serum, plasma or urine on Konelab and Indiko analyzers.

Hexokinase, Glucose

Glucose-SL Assay

Catalogue number 235-60, listed by Sekisui Diagnostics, LLC, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

ClearChem Diagnostics Inc. Glucose

Catalogue number GLU1140, listed by Clearchem Diagnostics Inc., under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Dimension® Flex® Reagent Cartridge Gluc

Glucose Flex® reagent cartridge, 1440 tests

Hexokinase, Glucose

CLC480 Chemistry Analyzer W/ISE

Catalogue number CLC480i, listed by Carolina Liquid Chemistries, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Atellica CH GluH_3

Glucose Hexokinase ( GluH_3) Atellica CH - RGT 6240T

Hexokinase, Glucose

Advia® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents

ADVIA Chemistry Glucose Hexokinase 3 is an in vitro diagnostic reagent for measuring glucose on the ADVIA 1650 Chemistry system. It accepts human serum, plasma, urine and cerebrospinal…

Hexokinase, Glucose

Pointe Glucose Reagent

Pointe Glucose Reagent packaged for use on the Mindray BA800. 8 x 66ml. For the in vitro quantitative measurement of glucose in serum.

Hexokinase, Glucose

Glucose-SL

Catalogue number 235-99, listed by Sekisui Diagnostics, LLC, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Carolina Liquid Chemistries Corp.® CLC720 GLU RGT KIT Product No. ST208

GLU (Glucose) 4 x 200 tests

Hexokinase, Glucose

Glucoquant GlucoseHK

3 catalogue numbers from 11929542216, listed by Roche Diagnostics Gmbh, Germany, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Pointe Scientific, Inc. Glucose

Pointe Scientific, Inc. Glucose Reagent is for the in vitro quantitative measurement of glucose in serum. Packaged for use on Olympus Analyzers. 6 x 66ml

Hexokinase, Glucose

Glucose

Catalogue number SK235-10, listed by Sekisui Diagnostics, LLC, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Teco Diagnostics Glucose (Hexokinase) Liquid Reagent

Teco Diagnostics Glucose Hexokinase (Liquid) Reagent Kit for TC-Matrix is used for the quantitative determination of glucose in serum or plasma on the TC Matrix analyzer.

Hexokinase, Glucose

Genchem™ Glucose Reagent

Catalogue number GEN-GLU4, listed by Genchem, Inc., United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Alinity

Alinity c Glucose Reagent Kit

Hexokinase, Glucose

Architect

2 catalogue numbers from 3L82-41, listed by Abbott Laboratories, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Yumizen C1200 Glucose HK

R1= 4x57mL R2= 3x26mL

Hexokinase, Glucose

Advia® Chemistry GLUH_c Glucose Hexokinase_3 Reagents, Concentrated

Glucose - ADVIA Chem. - Conc. RGT - 4x2100/4x1600 tests

Hexokinase, Glucose

Teco Diagnostics Glucose (Hexokinase) Reagent Set

Teco Diagnostics Glucose (Hexokinase) Reagent Set is used for the in vitro quantitative determination of glucose in human serum.

Hexokinase, Glucose

Carolina Liquid Chemistries Corp.® GLU RGT. KIT AU-208

GLU (Glucose) 3 x 250 tests

Hexokinase, Glucose

Carolina Liquid Chemistries Corp.® Glucose Reagent 88807

GLU3 (Glucose) - CX3 Reagent 1 x 500 mL

Hexokinase, Glucose

ABX Pentra Glucose HK CP

Catalogue number 1220001667, listed by Horiba ABX SAS, France, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.

Hexokinase, Glucose

Gluc-HK

A Glucose test system is a device intended for the quantitative in vitro determination of glucose concentration in serum, lithium plasma and urine

Hexokinase, Glucose

ABX Pentra Glucose PAP CP

Catalogue number 1220001668, listed by Horiba ABX SAS, France, under Hexokinase, Glucose. 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