FDA.reportPublic FDA data

Vitamin D 200 Series

Primary DI
00842365100205
Brand
Vitamin D 200 Series
Company
AB Sciex
Model
5044492
Published
2017-07-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PSL25-Oh-Vitamin D Mass Spectrometry Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSL25-Oh-Vitamin D Mass Spectrometry Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170019000Vitamin D 200M Assay for the Topaz SystemAb Sciex, LLC2017-05-18PSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842365100205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842365100205008423651002058423651002050842365100205

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a liquid chromatography/mass spectrometry (LC/MS) method. It is used in the investigation of conditions associated with vitamin D deficiency and for the assessment of vitamin D status during supplementation therapy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079640773
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842365100120Vitamin D 200 Series50453462017-11-06
00842365100144Vitamin D 200 Series50453522017-11-06
00842365100151Vitamin D 200 Series50453562017-11-06
00842365100168Vitamin D 200 Series50453602017-11-06
00842365100212Vitamin D 200 Series50444932017-07-07
00842365100021Vitamin D 200M Assay for the TopazTM System50444842017-07-07
00842365100090Vitamin D 200 Series50444852017-07-07
00842365100106Vitamin D 200 Series50444862017-07-07
00842365100113Vitamin D 200 Series50444872017-07-07
00842365100137Vitamin D 200 Series50444882017-07-07
00842365100175Vitamin D 200 Series50444892017-07-07
00842365100182Vitamin D 200 Series50444902017-07-07
00842365100199Vitamin D 200 Series50444912017-07-07
10842365100127Vitamin D 200 Series50453462017-11-06
10842365100141Vitamin D 200 Series50453522017-11-06
10842365100158Vitamin D 200 Series50453562017-11-06
10842365100165Vitamin D 200 Series50453602017-11-06
10842365100219Vitamin D 200 Series50444932017-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336232149Ionify Vitamin D 25Roche Diagnostics GmbHPSL2025-06-04
06438153007241Cascadion™ SM 25-Hydroxy Vitamin D Calibrator SetThermo Fisher Scientific OyPSL2020-03-02
06438153007258Cascadion™ SM 25-Hydroxy Vitamin D Control 1Thermo Fisher Scientific OyPSL2020-03-02
06438153007265Cascadion™ SM 25-Hydroxy Vitamin D Control 2Thermo Fisher Scientific OyPSL2020-03-02
06438153007272Cascadion™ SM 25-Hydroxy Vitamin D Control 3Thermo Fisher Scientific OyPSL2020-03-02
06438153007289Cascadion™ SM 25-Hydroxy Vitamin D Internal StandardThermo Fisher Scientific OyPSL2020-03-02
00842365100120Vitamin D 200 SeriesAB SciexPSL2017-11-06
00842365100144Vitamin D 200 SeriesAB SciexPSL2017-11-06
00842365100151Vitamin D 200 SeriesAB SciexPSL2017-11-06
00842365100168Vitamin D 200 SeriesAB SciexPSL2017-11-06
10842365100127Vitamin D 200 SeriesAB SciexPSL2017-11-06
10842365100141Vitamin D 200 SeriesAB SciexPSL2017-11-06
10842365100158Vitamin D 200 SeriesAB SciexPSL2017-11-06
10842365100165Vitamin D 200 SeriesAB SciexPSL2017-11-06
00842365100212Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100021Vitamin D 200M Assay for the TopazTM SystemAB SciexPSL2017-07-07
00842365100090Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100106Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100113Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100137Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100175Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100182Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100199Vitamin D 200 SeriesAB SciexPSL2017-07-07
10842365100219Vitamin D 200 SeriesAB SciexPSL2017-07-07