Mass Spectrometer, Clinical Use

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Shandong: 2 hold an FDA registration.

Labpeak Co., Ltd. Shandong
Scitek Global Co., Ltd. Shandong

How Is DOP Classified?

Mass Spectrometer, Clinical Use is FDA product code DOP, Class 1, 21 CFR 862.2860.

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 Do the Recalls Say?

The FDA has recorded 16 recalls under this product code since 2014. None was by a company in China. The root causes the FDA records most often are Software design (10), Component design/selection (4) and Software Design Change (1).

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

Mass Spectrometer, Clinical Use

K6460 Triple Quadrupole MS – ESI

Catalogue number K6460 Triple Quadrupole MS – ESI, listed by Agilent Technologies, Inc, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

MassARRAAY Dx

Catalogue number 260050, listed by Agena Bioscience Incorporated, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

QSight(Tm) 210 Screening System

The QSight™ 210 MD Screening System includes a semi-automated triple quadrupole detector intended to identify compounds in human samples by ionizing the compounds and separating the…

Mass Spectrometer, Clinical Use

AB Sciex Triple Quad™ 4500MD

The 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organic compounds in human specimens by ionizing the compound…

Mass Spectrometer, Clinical Use

Calibrant

Catalogue number 00436, listed by Agena Bioscience Incorporated, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

APCI-8050 SET

Catalogue number 225-19601-55, listed by Shimadzu Corp., United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

LCMS-8045CL

Catalogue number 225-31800-54, listed by Shimadzu Corp., United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

Citrine Triple Quad™ MS/MS

The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organic compounds in human specimens by ionizing the compound…

Mass Spectrometer, Clinical Use

Cobas I 601

Catalogue number 10271582001, listed by Roche Diagnostics Gmbh, Germany, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

Qsight 225 MD Screening System

Catalogue number 2040-0030, listed by Wallac OY, Finland, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

LCMS-8040 CL

2 catalogue numbers from 225-19503-54, listed by Shimadzu Corp., United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

Xevo

Xevo TQ Absolute XR IVD

Mass Spectrometer, Clinical Use

MassARRAY Clean Resin 28g

Catalogue number 8040, listed by Agena Bioscience Incorporated, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

Sercon

Abca GAS Isotope Ratio Mass Spectrometer Systems

Mass Spectrometer, Clinical Use

Qsight 210 MD Screening System

Catalogue number 2040-0010, listed by Wallac OY, Finland, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

CPM Dx

Catalogue number 31245, listed by Agena Bioscience Incorporated, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

AB Sciex Qtrap® 4500MD

The 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organic compounds in human specimens by ionizing the compound…

Mass Spectrometer, Clinical Use

SpectroChip Standalone Chip Only)

Catalogue number 8608, listed by Agena Bioscience Incorporated, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

Cobas I 601 SBL

Catalogue number 10271574001, listed by Roche Diagnostics Gmbh, Germany, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

SpectroChip CPM Kit (10×96)

Catalogue number 10600F, listed by Agena Bioscience Incorporated, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

K6460 Triple Quadrupole MS – AJS

Catalogue number K6460 Triple Quadrupole MS – AJS, listed by Agilent Technologies, Inc, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

Cobas Pro I 601 BL

Catalogue number 10271612001, listed by Roche Diagnostics Gmbh, Germany, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

TopazTM System

Catalogue number 5050412, listed by AB Sciex (Manufacturing), under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

Citrine Qtrap MS/MS

The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organic compounds in human specimens by ionizing the compound…

Mass Spectrometer, Clinical Use

Triple Quad™ 4500MD

Catalogue number 5312404, listed by AB Sciex (Manufacturing), under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

LCMS-8060 CL

2 catalogue numbers from 225-27810-54, listed by Shimadzu Corp., United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

SpectroChip CPM Kit (2×96)

Catalogue number 10610F, listed by Agena Bioscience Incorporated, United States, under Mass Spectrometer, Clinical Use. 2 manufacturers in China are registered for this product code.

Mass Spectrometer, Clinical Use

LCMS-8050 CL

3 catalogue numbers from 225-19600-22, listed by Shimadzu Corp., United States, under Mass Spectrometer, Clinical Use. 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