Vitamin D 200M Assay for the TopazTM System

GUDID 00842365100021

AB Sciex

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• Primary Device ID: 00842365100021
• NIH Device Record Key: 4619d455-b997-4f63-bd67-419921a8a323
• Commercial Distribution Discontinuation: 2017-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vitamin D 200M Assay for the TopazTM System
• Version Model Number: 5044484
• Company DUNS: 079640773
• Company Name: AB Sciex
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00842365100021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170019

FDA Product Code

• PSL: 25-Oh-Vitamin D Mass Spectrometry Test System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-07

Devices Manufactured by AB Sciex

• 00842365100021 - Vitamin D 200M Assay for the TopazTM System: 2018-07-06
• 00842365100021 - Vitamin D 200M Assay for the TopazTM System: 2018-07-06
• 00842365100090 - Vitamin D 200 Series: 2018-07-06
• 00842365100106 - Vitamin D 200 Series: 2018-07-06
• 00842365100113 - Vitamin D 200 Series: 2018-07-06
• 10842365100127 - Vitamin D 200 Series: 2018-07-06
• 00842365100137 - Vitamin D 200 Series: 2018-07-06
• 10842365100141 - Vitamin D 200 Series: 2018-07-06
• 10842365100158 - Vitamin D 200 Series: 2018-07-06