FDA.reportPublic FDA data

Ionify Vitamin D 25

Primary DI
07613336232149
Brand
Ionify Vitamin D 25
Company
Roche Diagnostics GmbH
Model
09634622160
Catalog number
09634622160
Device description
Ionify 25-Hydroxy Vitamin D total
Published
2025-06-04
Public version status
Update
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336232149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336232149076133362321497613336232149

GMDN Terms#

Term, Definition table
TermDefinition
Multiple steroid hormone IVD, kit, mass spectrometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple steroid hormones in a clinical specimen, using a mass spectrometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00842365100205Vitamin D 200 SeriesAB SciexPSL2017-07-07
10842365100219Vitamin D 200 SeriesAB SciexPSL2017-07-07