FDA.reportPublic FDA data

ROCHE MOLECULAR SYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22434712243471ROCHE MOLECULAR SYSTEMS, INC.1N2026-01-011080 US Highway 202 South Branchburg NJ US 08876
30041410783004141078ROCHE MOLECULAR SYSTEMS, INC.1N2026-01-014300 HACIENDA DRIVE PLEASANTON CA US 94588

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1997421390026319P200014cobas® EZH2 Mutation TestOWD2020-06-18
1997711390026319P200014cobas® EZH2 Mutation TestOWD2020-06-18
1997421365813454P190028cobas HPV for use on the cobas 6800/8800 SystemsMAQ2020-04-03
1997711365813454P190028cobas HPV for use on the cobas 6800/8800 SystemsMAQ2020-04-03
1997421570794295P160041COBAS CMVPAB2017-06-01
1997711570794295P160041COBAS CMVPAB2017-06-01
1997421098831314P150047cobas EGFR MUTATION TEST v2OWD2016-06-01
1997711098831314P150047cobas EGFR MUTATION TEST v2OWD2016-06-01
1997421396788287P150015COBAS HCV TESTMZP2015-10-14
1997711396788287P150015COBAS HCV TESTMZP2015-10-14
1997421359806188P150014COBAS HBV TESTMKT2015-10-14
1997711359806188P150014COBAS HBV TESTMKT2015-10-14
1997421214322309P140023COBAS KRAS MUTATION TESTOWD2015-05-07
1997711214322309P140023COBAS KRAS MUTATION TESTOWD2015-05-07
1997421492829540P120019COBAS EGFR MUTATION TESTOWD2013-05-14
1997711492829540P120019COBAS EGFR MUTATION TESTOWD2013-05-14
1997421044053797P110037COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)PAB2012-07-05
1997711044053797P110037COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)PAB2012-07-05
1997421328295118P110020COBAS 4800 BRAF V600 MUTATION TESTOWD2011-08-17
1997711328295118P110020COBAS 4800 BRAF V600 MUTATION TESTOWD2011-08-17
1997422012092563P100020COBAS HPV TESTMAQ2011-04-19
1997712012092563P100020COBAS HPV TESTMAQ2011-04-19
1997711297247710P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TESTMZP2008-10-30
1997421297247710P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TESTMZP2008-10-30
1997421356533795P050028COBAS TAQMAN HBV TESTMKT2008-09-04
1997711356533795P050028COBAS TAQMAN HBV TESTMKT2008-09-04
1997711447406489K964506ROCHE COBAS AMPLICOR ANALYZERJJF1997-05-21
1997421894342244K260021cobas® BV/CVPQA2026-07-16
1997711894342244K260021cobas® BV/CVPQA2026-07-16
1997711670861153K253759cobas liat CT/NG/MG nucleic acid testQEP2026-05-15
1997421670861153K253759cobas liat CT/NG/MG nucleic acid testQEP2026-05-15
1997711710901118K243863Opulus™ Lymphoma PrecisionQIH2025-05-30
1997421774110026K243753cobas liat Bordetella panel nucleic acid testOZZ2025-11-20
1997711774110026K243753cobas liat Bordetella panel nucleic acid testOZZ2025-11-20
1997421547201773K243455cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF2025-07-31
1997711547201773K243455cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF2025-07-31
1997421448607452K243406cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testQOF2025-04-25
1997711448607452K243406cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testQOF2025-04-25
1997421572568139K243400cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testQOF2025-04-25
1997711572568139K243400cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testQOF2025-04-25
1997711834809751K243346cobas liat SARS-CoV-2 v2 nucleic acid testQWR2025-04-11
1997421834809751K243346cobas liat SARS-CoV-2 v2 nucleic acid testQWR2025-04-11
1997421611381171K240217cobas® liat CT/NG nucleic acid testQEP2025-01-17
1997711611381171K240217cobas® liat CT/NG nucleic acid testQEP2025-01-17
1997421261881002K240197cobas® liat CT/NG/MG nucleic acid testQEP2025-01-16
1997711261881002K240197cobas® liat CT/NG/MG nucleic acid testQEP2025-01-16
1997421640328398K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemQWR2023-12-04
1997711640328398K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemQWR2023-12-04
1997711029264867K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemQOF2023-07-27
1997421029264867K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemQOF2023-07-27
1997421132001277K221007cobas HCVMZP2022-11-04
1997711132001277K221007cobas HCVMZP2022-11-04
1997421364073200K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsQQX2022-10-22
1997711364073200K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsQQX2022-10-22
1997711145259106K203220cobas BKVQLX2021-01-29
1997421145259106K203220cobas BKVQLX2021-01-29
1997711419446411K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQMI2020-09-02
1997421419446411K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQMI2020-09-02
1997421297293882K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control KitQEP2019-05-22
1997711297293882K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control KitQEP2019-05-22
1997421113598221K173887cobas CT/NG for use on cobas 6800/8800 systemsLSL2018-03-21
1997711113598221K173887cobas CT/NG for use on cobas 6800/8800 systemsLSL2018-03-21
1997421042701125K172913cobas Factor II and Factor V TestNPR2018-01-12
1997711040213773K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZN2017-09-12
1997421040213773K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZN2017-09-12
1997711568095057K163184cobas® CT/NG v2.0 TestLSL2017-02-09
1997421568095057K163184cobas® CT/NG v2.0 TestLSL2017-02-09
1997421504629507K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemOCC2016-07-25
1997711504629507K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemOCC2016-07-25
1997421734084746K150617cobas HSV 1 and 2 TestOQO2015-06-01
1997711734084746K150617cobas HSV 1 and 2 TestOQO2015-06-01
1997421573811548K142721cobas MRSA/SA TestNQX2014-12-17
1997711573811548K142721cobas MRSA/SA TestNQX2014-12-17
1997421738692858K142422cobas Cdiff TestOZN2015-05-20
1997711738692858K142422cobas Cdiff TestOZN2015-05-20
1997421891892177K141338LIAT STREP A ASSAYPGX2014-11-04
1997711891892177K141338LIAT STREP A ASSAYPGX2014-11-04
1997421832776303K140887COBAS CT/NG V2.0 TESTLSL2014-05-05
1997711832776303K140887COBAS CT/NG V2.0 TESTLSL2014-05-05
1997421007000899K132270COBAS CT/NG V2.0 TESTLSL2013-12-02
1997711007000899K132270COBAS CT/NG V2.0 TESTLSL2013-12-02
1997421862878436K111387LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZEROCC2011-08-04
1997711862878436K111387LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZEROCC2011-08-04
1997421594125537K110923COBAS 4800 CT / NG TESTMKZ2012-01-24
1997711594125537K110923COBAS 4800 CT / NG TESTMKZ2012-01-24
1997421931757536K091409LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727NQX2010-07-06
1997711931757536K091409LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727NQX2010-07-06
1997711528507523K033734LIGHTCYCLER INSTRUMENT VERSION 1.2JJF2003-12-17
1997711276700842K012966ROCHE COBAS TAQMAN ANALYZERJJF2002-02-01
1997421610484094DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQLX2020-07-30
1997711610484094DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQLX2020-07-30
1997711826967944DEN190016cobas vivoDx MRSAQIV2019-12-05
1997421826967944DEN190016cobas vivoDx MRSAQIV2019-12-05
1997421917596469BP190360
1997711917596469BP190360
1997421642967897BP150262
1997711642967897BP150262
1997421856699483BP050069
1997711856699483BP050069
1997711954295291BK251286
1997421954295291BK251286
1997711220507468BK251233
1997421220507468BK251233
1997711827747672BK140196
1997711718067566BK140195
1997421519980617
1997421647147344
1997421770588921
1997421102751767
1997711105418697
1997421105418697
1997421160335682
1997421171565720
1997421201101636
1997421220987228
1997421241756034
1997421273333367
1997711273639106
1997421273639106
1997421296806556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEP82026-05-15
QOF82025-07-31
LSL82018-03-21
MZP62022-11-04
OWD62015-05-07
QWR42025-04-11
QLX42021-01-29
OZN42017-09-12
PAB42017-06-01
OCC42016-07-25
MKT42015-10-14
NQX42014-12-17
JJF32003-12-17
PQA22026-07-16
OZZ22025-11-20
QQX22022-10-22
QMI22020-09-02
OWD 22020-06-18
MAQ 22020-04-03
QIV22019-12-05
OQO22015-06-01
PGX22014-11-04
MKZ22012-01-24
MAQ22011-04-19
QIH12025-05-30
NPR12018-01-12

PMA#

200 records. Showing 1-40. Next

PMN#

43 records. Showing 1-40. Next

GUDID#

172 records. Showing 1-40. Next