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.

Registry build 21.09.26
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 TopazTM System
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 2017-12-21
Record revised 2022-09-16 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Distribution end date 2020-07-23

Catalogue Numbers

Catalogue numbers for TopazTM System
Catalogue number Size Status
5050412 Withdrawn

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
Citrine Qtrap MS/MS 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