Chloride electrode 03246353001

GUDID 07613336227787

Roche Diagnostics GmbH

Chloride (Cl-) electrode IVD
Primary Device ID07613336227787
NIH Device Record Keyd724f0dc-ad1c-4f2a-b016-91a5fd21b0ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameChloride electrode
Version Model Number03246353001
Catalog Number03246353001
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS107613336227787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGZELECTRODE, ION-SPECIFIC, CHLORIDE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-13
Device Publish Date2025-03-05

Devices Manufactured by Roche Diagnostics GmbH

07613336227763 - Sodium electrode2025-03-13
07613336227770 - Potassium electrode2025-03-13
07613336227787 - Chloride electrode2025-03-13
07613336227787 - Chloride electrode2025-03-13
07613336227794 - Reference electrode2025-03-13
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07613336228487 - Elecsys Anti-HBc II2025-02-27
07613336228500 - Elecsys HIV Duo2025-02-27
07613336183212 - PreciControl HIV Gen II2025-02-27

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