Xevo

Xevo TQ Absolute XR IVD

Registry build 21.09.26
2manufacturers in China registered for this device type
6catalogue numbers in this listing

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 Xevo
Listed by Waters Corporation, United States
FDA product code DOP
Device type Mass Spectrometer, Clinical Use
Device class Class 1
Regulation 21 CFR 862.2860
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-10-05
Record revised 2022-09-16 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Xevo
Catalogue number Size Status
186007833IVD In distribution
186005833IVD In distribution
186011468IVD In distribution
186008453IVD In distribution
186005453IVD In distribution
186009782IVD In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Citrine Qtrap MS/MS 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

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