BCM for cobas 8100 08368449001

GUDID 07613336156520

Roche Diagnostics GmbH

Specimen processing instrument IVD, automated
Primary Device ID07613336156520
NIH Device Record Keya0539cad-f208-4996-862a-ae1bb88ef046
Commercial Distribution StatusIn Commercial Distribution
Brand NameBCM for cobas 8100
Version Model Number08368449001
Catalog Number08368449001
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336156520 [Primary]

FDA Product Code

JQPCalculator/data processing module, 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 Date2020-12-29
Device Publish Date2020-12-21

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