cobas® Liat® Analyzer Software 3.3 09260994001

GUDID 07613336179970

Roche Molecular Systems, Inc.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated
Primary Device ID07613336179970
NIH Device Record Keybbdb212e-61a5-4245-9e92-7b5d9b532bee
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas® Liat® Analyzer Software 3.3
Version Model Number09260994001
Catalog Number09260994001
Company DUNS071674100
Company NameRoche Molecular Systems, Inc.
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 Datetrue
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
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]
GS107613336179970 [Primary]

FDA Product Code

OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system
OOIreal time Nucleic acid amplification system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by Roche Molecular Systems, Inc.

00875197005592 - cobas® EZH2 Mutation Test2020-08-10
07613336179970 - cobas® Liat® Analyzer Software 3.32020-07-31
07613336179970 - cobas® Liat® Analyzer Software 3.32020-07-31
00875197006216 - cobas PCR Media2020-07-09
00875197006223 - cobas® Sample Prep Buffer2020-07-09
00875197006230 - cobas® Specimen Pre-Extraction Reagent2020-07-09
00875197006247 - cobas® prime User Workflow Reagent Bottle2020-07-09
07613336171288 - cobas® prime Process Plus Module2020-07-09
07613336171295 - cobas® prime Secondary Tube Tray2020-07-09

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.