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

Other Devices From This Company#

Primary DI, Brand, Model table
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07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

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