cobas i 601 10271582001

GUDID 07613336231364

Roche Diagnostics GmbH

Liquid chromatography/mass spectrometry (LC/MS) analyser IVD
Primary Device ID07613336231364
NIH Device Record Key8776eed0-ff6b-4781-b7d9-e11ac5bec2ef
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas i 601
Version Model Number10271582001
Catalog Number10271582001
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336231364 [Primary]

FDA Product Code

DOPMASS SPECTROMETER, CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-08
Device Publish Date2025-07-31

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07613336231364 - cobas i 6012025-08-08
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