TopazTM System

GUDID 00842365100038

AB SCIEX (MANUFACTURING)

Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD, semi-automated Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD

• Primary Device ID: 00842365100038
• NIH Device Record Key: 9e5eabd5-f061-4a6e-a5cb-02ee2b2a8f83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TopazTM System
• Version Model Number: 5050412
• Company DUNS: 595281292
• Company Name: AB SCIEX (MANUFACTURING)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842365100038 [Primary]

FDA Product Code

• DOP: Mass Spectrometer, Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-21

Devices Manufactured by AB SCIEX (MANUFACTURING)

• 00842365100519 - Jasper HPLC System: 2022-10-06 The Jasper HPLC system is a high pressure liquid chromatography system for clinical use intended to separate one or more compoun
• 00842365100533 - Citrine Triple Quad™ MS/MS: 2022-10-06 The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or orga
• 00842365100540 - Citrine QTRAP MS/MS: 2022-10-06 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™ 4500MD: 2022-10-06 The 4500MD system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organ
• 00842365102063 - AB SCIEX QTRAP® 4500MD: 2022-10-06 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