FDA.reportPublic FDA data

Vitamin D 200 Series

Primary DI
10842365100141
Brand
Vitamin D 200 Series
Company
AB Sciex
Model
5045352
Published
2017-11-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10842365100141PackageGS13Not in Commercial Distribution
00842365100144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084236510014110842365100141
00842365100144008423651001448423651001440842365100144

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00842365100205Vitamin D 200 Series50444922017-07-07
10842365100127Vitamin D 200 Series50453462017-11-06
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
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
00842365100205Vitamin D 200 SeriesAB SciexPSL2017-07-07
10842365100219Vitamin D 200 SeriesAB SciexPSL2017-07-07