Ionify ControlSet Steroids and Vitamin D 09646965160

GUDID 07613336232194

Roche Diagnostics GmbH

Multiple steroid hormone IVD, control
Primary Device ID07613336232194
NIH Device Record Key50d87aee-ca7f-4910-bba3-29e17a85ca33
Commercial Distribution StatusIn Commercial Distribution
Brand NameIonify ControlSet Steroids and Vitamin D
Version Model Number09646965160
Catalog Number09646965160
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
GS107613336232194 [Primary]

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-03
Device Publish Date2025-06-25

Devices Manufactured by Roche Diagnostics GmbH

07613336232156 - Ionify CalSet Steroids and Vitamin D2025-07-03
07613336232194 - Ionify ControlSet Steroids and Vitamin D2025-07-03
07613336232194 - Ionify ControlSet Steroids and Vitamin D2025-07-03
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

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