cobas c 503 analytical unit 08463662001

GUDID 07613336158784

Roche Diagnostics GmbH

Multi-modality clinical specimen analysis system IVD
Primary Device ID07613336158784
NIH Device Record Keyf046634e-f234-4bc9-9b30-eb81fd1352de
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas c 503 analytical unit
Version Model Number08463662001
Catalog Number08463662001
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
GS107613336158784 [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 Date2020-03-16
Device Publish Date2020-03-06

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