TopazTM System

GUDID 00842365100038

AB SCIEX (MANUFACTURING)

Mass spectrometry analyser IVD, semi-automated
Primary Device ID00842365100038
NIH Device Record Key9e5eabd5-f061-4a6e-a5cb-02ee2b2a8f83
Commercial Distribution StatusIn Commercial Distribution
Brand NameTopazTM System
Version Model Number5050412
Company DUNS595281292
Company NameAB SCIEX (MANUFACTURING)
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842365100038 [Primary]

FDA Product Code

DOPMass Spectrometer, Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-21

Devices Manufactured by AB SCIEX (MANUFACTURING)

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00842365100533 - Citrine Triple Quad™ MS/MS2022-10-06 The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or orga
00842365100540 - Citrine QTRAP MS/MS2022-10-06 The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or orga
00842365102049 - AB SCIEX Triple Quad™ 4500MD2022-10-06 The 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organ
00842365102063 - AB SCIEX QTRAP® 4500MD2022-10-06 The 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organ
00842365100038 - TopazTM System 2018-03-29
00842365100038 - TopazTM System 2018-03-29

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