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…

Registry build 21.09.26

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 under investigation and separating the resulting ions by means of an electrical field according to their mass.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Shandong.

Chinese manufacturers registered for FDA product code DOP
Manufacturer City Province Registered as Device types
Labpeak Co., Ltd. Jinan Shandong Manufacturer 43
Scitek Global Co., Ltd. Jinan Shandong Manufacturer 43

Record

Regulatory record for Citrine Qtrap MS/MS
Listed by AB Sciex (Manufacturing)
FDA product code DOP
Device type Mass Spectrometer, Clinical Use
Device class Class 1
Regulation 21 CFR 862.2860
Premarket notification Exempt
Record published 2022-09-28

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Citrine Qtrap MS/MS
Catalogue number Size Status
5050807 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Xevo Waters Corporation 6
LCMS-8050 CL Shimadzu Corp. 3
LCMS-8060 CL Shimadzu Corp. 2
LCMS-8040 CL Shimadzu Corp. 2
SpectroChip CPM Kit (2×96) Agena Bioscience Incorporated 1
Triple Quad™ 4500MD AB Sciex (Manufacturing) 1
TopazTM System AB Sciex (Manufacturing) 1
cobas pro i 601 BL Roche Diagnostics Gmbh 1
K6460 Triple Quadrupole MS → AJS Agilent Technologies, Inc 1
SpectroChip CPM Kit (10×96) Agena Bioscience Incorporated 1
cobas i 601 SBL Roche Diagnostics Gmbh 1
SpectroChip Standalone Chip Only) Agena Bioscience Incorporated 1

Showing 12 of 27. All products under Mass Spectrometer, Clinical Use

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Citrine Qtrap MS/MS
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Ab Sciex, LLC UDI-DI 2023-08-30 Class II Component design/selection In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There 10

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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