cobas pro e 801 SBL-DL 08462984001

GUDID 07613336158654

Roche Diagnostics GmbH

Ion-selective analyser IVD, automated Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD Ion-selective analyser IVD
Primary Device ID07613336158654
NIH Device Record Key0c758f77-1153-4544-b7c7-fad9a4a93cfd
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas pro e 801 SBL-DL
Version Model Number08462984001
Catalog Number08462984001
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 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
GS107613336158654 [Primary]

FDA Product Code

JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

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