cobas pro SSU 09205632001

GUDID 07613336179499

Roche Diagnostics GmbH

Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated Ion-selective analyser IVD, automated 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 ID07613336179499
NIH Device Record Keyeef0485f-e35b-43b0-b72f-f2090dc23be6
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas pro SSU
Version Model Number09205632001
Catalog Number09205632001
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336179499 [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 Date2021-09-13
Device Publish Date2021-09-03

Devices Manufactured by Roche Diagnostics GmbH

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04015630929702 - cobas Elecsys AntiTPO2024-02-16
04015630939626 - Elecsys Anti-TPO2024-02-16
04015630899548 - Elecsys CalSet TUptake2024-02-05
04015630899579 - Elecsys Tuptake Assay2024-02-05
04015630940530 - Elecsys T-Uptake2024-02-05
07613336130513 - Alanine Aminotransferase acc. to IFCC II2024-02-05
07613336130537 - Aspartate Aminotransferase acc. to IFCC II2024-01-22

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