Analyzer, Chemistry, Micro, for Clinical Use

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Henan, Hubei and Jiangsu: 3 hold an FDA registration.

Autobio Labtec Instruments Co., Ltd. Henan
Getein Biotech, Inc. Jiangsu
Wuhan Landing Intelligence Medical Co., Ltd. Hubei

What Is FDA Product Code JJF?

Analyzer, Chemistry, Micro, For Clinical Use is FDA product code JJF, Class 1, 21 CFR 862.2170.

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 2003. None was by a company in China. The root causes the FDA records most often are Component design/selection (3), Nonconforming Material/Component (2) and Device Design (1).

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

Analyzer, Chemistry, Micro, For Clinical Use

ISE DIL URN

The product is required for urine samples. Urine samples must be diluted by a factor of 10 to perform urine measurement. The host analyser will mix the diluent and sample before dispensing…

Analyzer, Chemistry, Micro, For Clinical Use

Cholestech LDX™

Cholestech LDX™ Analyzer

Analyzer, Chemistry, Micro, For Clinical Use

Wash Conc. 3

Catalogue number RX3946, listed by Randox Laboratories Limited, United Kingdom, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

V-Twin®

Catalogue number 6002-800, listed by VitalScientific B.V., Netherlands, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

Cobas® TaqMan®

Catalogue number 03121453001, listed by Roche Molecular Systems, Inc., United States, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

Sabs

This product is used for checking proper functioning of the sample fluid metering system as well as the photometric measuring system.

Analyzer, Chemistry, Micro, For Clinical Use

Wash Concentrate 1

For use as a cleaning solution on automated analyzers. 6 x 25 ml

Analyzer, Chemistry, Micro, For Clinical Use

Wash Conc. 2

Catalogue number RX3962, listed by Randox Laboratories Limited, United Kingdom, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

Alere Cholestech LDX®

Alere Cholestech LDX® Analyzer

Analyzer, Chemistry, Micro, For Clinical Use

Cobas C 311

Catalogue number 4826876001, listed by Roche Diagnostics Gmbh, Germany, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

Cobas C 501 Module

Catalogue number 4745914001, listed by Roche Diagnostics Gmbh, Germany, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

RX Daytona

RX Daytona is an automated clinical chemistry analyser complete with dedicated analyser software.

Analyzer, Chemistry, Micro, For Clinical Use

Cobas 6000 Core Unit

Catalogue number 4745868001, listed by Roche Diagnostics Gmbh, Germany, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

Wash Concentrate 3

This product will be used as a concentrated wash solution on automated analyzers. 6 x 25 ml.

Analyzer, Chemistry, Micro, For Clinical Use

MedTest DX Wash Solution for the BS200

MedTest DX BS200 Wash Solution is packaged for use with the Mindray BS200 Analyzer and intended for cleaning after reagent testing. 4 x 40ml.

Analyzer, Chemistry, Micro, For Clinical Use

Spotcheck

Uridyltransferase Active Cartridge

Analyzer, Chemistry, Micro, For Clinical Use

Diamedix

MAGO Plus chemistry analyzer

Analyzer, Chemistry, Micro, For Clinical Use

Wash Concentrate 2

For use as a cleaning solution on automated analyzers. 6 x 25 ml

Analyzer, Chemistry, Micro, For Clinical Use

Cl Soln

Catalogue number RX3973, listed by Randox Laboratories Limited, United Kingdom, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

Rabs

The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photometric measuring system.

Analyzer, Chemistry, Micro, For Clinical Use

Liaison® Easy Starter Kit

UK manufactured product

Analyzer, Chemistry, Micro, For Clinical Use

NS

This product should be used in conjunction with RX series reagents to dilute samples prior to assay

Analyzer, Chemistry, Micro, For Clinical Use

Wash Conc. 1

Catalogue number RX3963, listed by Randox Laboratories Limited, United Kingdom, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

Soln Wash

This should be run once a day to prevent protein build up or at 8 hour intervals if the ISE module performs more than 50 samples per day. Cleaning solution may be aspirated from a sample…

Analyzer, Chemistry, Micro, For Clinical Use

COBAS®TaqMan® 48 Analyzer

Catalogue number 03279332001, listed by Roche Molecular Systems, Inc., United States, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

Liaison® XL

Catalogue number I0050, listed by Diasorin Inc., United States, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.

Analyzer, Chemistry, Micro, For Clinical Use

AWS

This product should be used in conjunction with RX SERIES reagents to clean probes and cuvettes.

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