cobas 6000 c501 module 7790198001

GUDID 04015630946402

Roche Diagnostics GmbH

Multiple clinical chemistry analyser IVD, laboratory, automated
Primary Device ID04015630946402
NIH Device Record Keyf4a71734-962d-42fe-a369-3a621fda04c8
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas 6000 c501 module
Version Model Number7790198001
Catalog Number7790198001
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 Numbertrue
Manufacturing Datetrue
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
GS104015630946402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), 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 Date2016-09-23

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