Vitamin D 200M Assay for the TopazTM System

GUDID 00842365100021

AB Sciex

Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS)
Primary Device ID00842365100021
NIH Device Record Key4619d455-b997-4f63-bd67-419921a8a323
Commercial Distribution Discontinuation2017-12-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVitamin D 200M Assay for the TopazTM System
Version Model Number5044484
Company DUNS079640773
Company NameAB Sciex
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842365100021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSL25-Oh-Vitamin D Mass Spectrometry Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-07

Devices Manufactured by AB Sciex

00842365100021 - Vitamin D 200M Assay for the TopazTM System2018-07-06
00842365100021 - Vitamin D 200M Assay for the TopazTM System2018-07-06
00842365100090 - Vitamin D 200 Series2018-07-06
00842365100106 - Vitamin D 200 Series2018-07-06
00842365100113 - Vitamin D 200 Series2018-07-06
10842365100127 - Vitamin D 200 Series2018-07-06
00842365100137 - Vitamin D 200 Series2018-07-06
10842365100141 - Vitamin D 200 Series2018-07-06
10842365100158 - Vitamin D 200 Series2018-07-06

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