Vitamin D 200 Series

GUDID 00842365100090

AB Sciex

Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

• Primary Device ID: 00842365100090
• NIH Device Record Key: f20d9353-9bbc-4821-ba2f-be7855b50a60
• Commercial Distribution Discontinuation: 2017-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vitamin D 200 Series
• Version Model Number: 5044485
• 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: false
• 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	00842365100090 [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

On-Brand Devices [Vitamin D 200 Series]

• 10842365100219: 5044493
• 00842365100205: 5044492
• 00842365100199: 5044491
• 00842365100182: 5044490
• 00842365100175: 5044489
• 10842365100165: 5045360
• 10842365100158: 5045356
• 10842365100141: 5045352
• 00842365100137: 5044488
• 10842365100127: 5045346
• 00842365100113: 5044487
• 00842365100106: 5044486
• 00842365100090: 5044485