Ionify Vitamin D 25

Basic Information

• Brand Name: Ionify Vitamin D 25
• Primary DI: 07613336232149
• Version / Model: 09634622160
• Catalog Number: 09634622160
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-04
• Public Version: 2
• Public Version Date: 2025-09-26
• Public Version Status: Update
• Public Device Record Key: 4228ca26-751f-41f4-a8aa-e3df5df19872

Device Description

Ionify 25-Hydroxy Vitamin D total

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PSL	25-OH-Vitamin D Mass Spectrometry test system	Clinical Chemistry	862.1840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59017	Multiple steroid hormone IVD, kit, mass spectrometry	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336232149	GS1