cobas c 311 4826876001

GUDID 04015630925551

Roche Diagnostics GmbH

Multiple clinical chemistry analyser IVD, laboratory, automated
Primary Device ID04015630925551
NIH Device Record Key69e3f441-675a-49af-b4b5-3bb3c6ae7534
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas c 311
Version Model Number4826876001
Catalog Number4826876001
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS104015630925551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJFANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-09-20

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