cobas pro SB 09205675001

GUDID 07613336179505

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 ID07613336179505
NIH Device Record Key0015a8f6-6f99-401c-9a92-36ca2945927b
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas pro SB
Version Model Number09205675001
Catalog Number09205675001
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
GS107613336179505 [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

07613336224816 - ONLINE TDM Methotrexate2024-04-02
07613336224823 - ONLINE TDM Methotrexate 2024-04-02
07613336224830 - MTX Calibrator2024-04-02
07613336217689 - Elecsys ProBNP II2024-02-27
04015630929702 - cobas Elecsys AntiTPO2024-02-16
04015630939626 - Elecsys Anti-TPO2024-02-16
04015630899548 - Elecsys CalSet TUptake2024-02-05
04015630899579 - Elecsys Tuptake Assay2024-02-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.