cobas pro Transport Belt (2 AU, 2 ISE) 09205713001

GUDID 07613336179536

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 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 ID07613336179536
NIH Device Record Key660bbc51-cb3d-4f35-b498-dbd364a551ba
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas pro Transport Belt (2 AU, 2 ISE)
Version Model Number09205713001
Catalog Number09205713001
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 Batchtrue
Serial Numberfalse
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
GS107613336179536 [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 Date2021-09-14
Device Publish Date2021-09-06

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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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