cobas® Strep A Nucleic acid test for use on the cobas® Liat® System 07341911190

GUDID 00875197005622

Roche Molecular Systems, Inc.

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00875197005622
NIH Device Record Key7c32ee73-1d77-4043-954a-3351020b029e
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas® Strep A Nucleic acid test for use on the cobas® Liat® System
Version Model Number07341911190
Catalog Number07341911190
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100875197005622 [Primary]

FDA Product Code

PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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Trademark Results [cobas]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COBAS
COBAS
97134294 not registered Live/Pending
Roche Diagnostics Operations, Inc.
2021-11-19
COBAS
COBAS
97134211 not registered Live/Pending
Roche Diagnostics Operations, Inc.
2021-11-19
COBAS
COBAS
97134206 not registered Live/Pending
Roche Diagnostics Operations, Inc.
2021-11-19
COBAS
COBAS
78481887 3276336 Live/Registered
Roche Diagnostics Operations, Inc.
2004-09-10
COBAS
COBAS
78481062 3256896 Live/Registered
Roche Diagnostics Operations, Inc.
2004-09-09
COBAS
COBAS
78341250 2913258 Live/Registered
ROCHE DIAGNOSTICS OPERATIONS, INC.
2003-12-16
COBAS
COBAS
78341244 2911176 Live/Registered
ROCHE DIAGNOSTICS OPERATIONS, INC.
2003-12-16
COBAS
COBAS
77257927 3487487 Live/Registered
Roche Diagnostics Operations, Inc.
2007-08-17
COBAS
COBAS
76512726 2977379 Live/Registered
ROCHE DIAGNOSTICS OPERATIONS, INC.
2003-05-08
COBAS
COBAS
73376129 1251382 Live/Registered
Roche Analytical Instruments, Inc.
1982-07-22
COBAS
COBAS
73376129 1251382 Live/Registered
ROCHE DIAGNOSTIC SYSTEMS, INC.
1982-07-22

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