Station, Pipetting and Diluting, for Clinical Use

Who Makes This Device Type in China?

5 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Shandong and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Biobase Biodustry(Shandong)Co., Ltd. Shandong
Bioteke Corporation (Wuxi) Co., Ltd. Jiangsu
Jiangsu Kangjian Medical Apparatus Co., Ltd. Jiangsu, contract manufacturer
Yantai Addcare Bio-Tech Co., Ltd. Shandong, contract manufacturer
Zhejiang Biorear Biotechnology Co., Ltd. Zhejiang

What Is FDA Product Code JQW?

Station, Pipetting And Diluting, For Clinical Use is FDA product code JQW, Class 1, 21 CFR 862.2750.

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 36 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Device Design (5), Nonconforming Material/Component (3) and Software design (2).

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

Station, Pipetting And Diluting, For Clinical Use

cobas&#x00AE Prime User Workflow Reagent Bottle

Catalogue number 08460426190, listed by Roche Molecular Systems, Inc., United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

50TS12V-SI

Catalogue number 50TS12V-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

405TSU-SI

Catalogue number 405TSU-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

50TS8-SI

Catalogue number 50TS8-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

Sprinter XL (Model 160 Samples, IFA)

Catalogue number YG 0033-0101-5, listed by Euroimmun Medizinische Labordiagnostika AG, Germany, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

URIVerse™

Catalogue number W095, listed by Copan Wasp, Italy, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

ELx405C-SI

Catalogue number ELx405C-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

405LSUVSQ-SI

Catalogue number 405LSUVSQ-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

Tomcat®

Tomcat® Instrument.

Station, Pipetting And Diluting, For Clinical Use

QuickGel Applicator Kit (Applicator, Base, Weights, Cup Tray)

Catalogue number 1274000, listed by Helena Laboratories, Corp., United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

Sprinter XL

Catalogue number YG 0033-0101, listed by Euroimmun Medizinische Labordiagnostika AG, Germany, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

cobas&#x00AE Prime Process Plus Module

Catalogue number 08987963001, listed by Roche Molecular Systems, Inc., United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

405LSHTV-SI

Catalogue number 405LSHTV-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

405TSRSQ-SI

Catalogue number 405TSRSQ-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

Super Z-12 Applicator Kit (12-Sample)

Catalogue number 4093, listed by Helena Laboratories, Corp., United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

Veya Dx 6

Catalogue number Veya Dx 6, listed by Tecan Schweiz AG, Switzerland, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

405LSRVSQ-SI

Catalogue number 405LSRVSQ-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

406PSUB2-SI

Catalogue number 406PSUB2-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

406PSU0LB-SI

Catalogue number 406PSU0LB-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

Rapid Capture System

Rapid Capture System: 1 catalogue number listed by Qiagen, Gmbh, Germany, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

Janus G3 NGS Express

JANUS G3 NGS Express, IVD

Station, Pipetting And Diluting, For Clinical Use

FP1000

FP 1000 Cell Preparation System

Station, Pipetting And Diluting, For Clinical Use

405LSUS-SI

Catalogue number 405LSUS-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

ELx405S-SI

Catalogue number ELx405S-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

Veya Dx 9

Catalogue number Veya Dx 9, listed by Tecan Schweiz AG, Switzerland, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

405TSUS-SI

Catalogue number 405TSUS-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

AcfS L and D Equipment Installation Bundle

Catalogue number 07759274001, listed by Roche Molecular Systems, Inc., United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

EUROLabLiquidHandler (45-10)

Catalogue number YG 0845-0101-10, listed by Euroimmun Medizinische Labordiagnostika AG, Germany, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

BSTCK2WR-SI

Catalogue number BSTCK2WR-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

50TS8V-SI

Catalogue number 50TS8V-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 manufacturers in China are registered for this product code.

Station, Pipetting And Diluting, For Clinical Use

50TS8MF-SI

Catalogue number 50TS8MF-SI, listed by Agilent Technologies, Inc, United States, under Station, Pipetting And Diluting, For Clinical Use. 5 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