Ionify Vitamin D 25 09634622160

GUDID 07613336232149

Roche Diagnostics GmbH

Multiple steroid hormone IVD, kit, mass spectrometry
Primary Device ID07613336232149
NIH Device Record Key4228ca26-751f-41f4-a8aa-e3df5df19872
Commercial Distribution StatusIn Commercial Distribution
Brand NameIonify Vitamin D 25
Version Model Number09634622160
Catalog Number09634622160
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS107613336232149 [Primary]

FDA Product Code

PSL25-OH-Vitamin D Mass Spectrometry test system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-12
Device Publish Date2025-06-04

Devices Manufactured by Roche Diagnostics GmbH

07613336232149 - Ionify Vitamin D 252025-06-12
07613336232149 - Ionify Vitamin D 252025-06-12
04015630924288 - sFlT-1 CalSet2025-04-15
04015630925407 - CalSet PlGF2025-04-15
07613336172094 - Elecsys sFlT-12025-04-15
07613336172124 - Elecsys PlGF2025-04-15
07613336220108 - PreciControl Rubella IgM2025-04-15
07613336230671 - Elecsys sFlT-12025-04-15
07613336230756 - Elecsys PlGF2025-04-15

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.