QSight(tm) 210 Screening System

GUDID 00812589020320

The QSight™ 210 MD Screening System includes a semi-automated triple quadrupole detector intended to identify compounds in human samples by ionizing the compounds and separating the resulting ions by means of an electrical and magnetic field according to their mass. The QSight™ 210 MD Screening System is suitable for use in clinical settings and should be operated by qualified laboratory personnel.

Perkinelmer Health Sciences Canada, Inc

Mass spectrometry analyser IVD, semi-automated

• Primary Device ID: 00812589020320
• NIH Device Record Key: a01781ea-b2c8-462c-8afb-8aca588006aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QSight(tm) 210 Screening System
• Version Model Number: BC004945
• Company DUNS: 202265331
• Company Name: Perkinelmer Health Sciences Canada, Inc
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812589020320 [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: 2017-11-13