cobas® HIV-1 09040803190

GUDID 00875197006407

Roche Molecular Systems, Inc.

HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00875197006407
NIH Device Record Keye8146f1d-3377-4a50-ba5c-607a54749d89
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas® HIV-1
Version Model Number09040803190
Catalog Number09040803190
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 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
GS100875197006407 [Primary]

FDA Product Code

MZFTest, HIV detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-22
Device Publish Date2021-12-10

Devices Manufactured by Roche Molecular Systems, Inc.

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04015630936557 - DOCKING STATION SHORT2022-09-16
00875197006445 - cobas® NHP Negative Control Kit2022-08-09
04015630929009 - cobas x 480 Analyzer2022-06-10
00875197006391 - cobas® HCV2021-12-22
00875197006407 - cobas® HIV-12021-12-22
00875197006407 - cobas® HIV-12021-12-22

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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