COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test 04902025190

GUDID 00875197002584

Roche Molecular Systems, Inc.

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00875197002584
NIH Device Record Keyad18b9a3-00b4-4030-9dbf-324eff4ebf95
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOBAS® AmpliPrep/ COBAS® TaqMan® CMV Test
Version Model Number04902025190
Catalog Number04902025190
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 Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100875197002584 [Primary]

FDA Product Code

PABCytomegalovirus (cmv) dna quantitative assay

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 Date2014-09-10

Devices Manufactured by Roche Molecular Systems, Inc.

04015630936540 - cobas p630 Pre-Analytical Pipettor2022-09-16
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
00875197006414 - cobas® HBV2021-12-22
00875197006421 - cobas® CMV2021-12-22

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

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