Chromatography (Liquid, Gel), Clinical Use

Which Manufacturers in China Make This?

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

Guang XI Fulaiming Biopharmaceutics Co., Ltd. Guangxi
Jiangsu Hongsheng Bioengineering Co., Ltd. Jiangsu

How Is KZR Classified?

Chromatography (Liquid, Gel), Clinical Use is FDA product code KZR, Class 1, 21 CFR 862.2260.

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.

Chromatography (Liquid, Gel), Clinical Use

Master Column

MassTox® TDM MasterColumn® Series A

Chromatography (Liquid, Gel), Clinical Use

Restrictor Capillary

Restrictor Capillary, MassChrom® Amino Acids and Acylcarnitines

Chromatography (Liquid, Gel), Clinical Use

Trap Column

Trap Column, MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 in serum/plasma

Chromatography (Liquid, Gel), Clinical Use

Precolumn Cartridge

Precolum Cartridge 4/10, Hippuric Acid, Methylhippuric Acids, Mandelic acid, Phenylglyoxylic Acid in urine

Chromatography (Liquid, Gel), Clinical Use

Analytical Column

Analytical Column, MassChrom® 3-epi-25-OH-Vitamin D3/D2 and 25-Vitamin D3/D2 in serum/plasma

Chromatography (Liquid, Gel), Clinical Use

Hplc Column

HPLC Column, Hippuric/Methylhippuric/Mandelic/Phenylglyoxylic Acids in urine

Chromatography (Liquid, Gel), Clinical Use

Which Manufacturers in China Make This?

How Is KZR Classified?

How Does It Reach the US Market?

Master Column

Restrictor Capillary

Trap Column

Precolumn Cartridge

Analytical Column

Hplc Column

Where China Actually Supplies