FDA.reportPublic FDA data

Roche

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18232601823260ROCHE DIAGNOSTICS OPERATIONS INC1Y2026-01-019115 Hague Rd Indianapolis IN US 46250
22434712243471ROCHE MOLECULAR SYSTEMS, INC.1N2026-01-011080 US Highway 202 South Branchburg NJ US 08876
30037951163003795116ROCHE DIAGNOSTICS INTERNATIONAL LTD.1N2026-01-01FORRENSTRASSE 2 ROTKREUZ Zug CH CH-6343
30041410783004141078ROCHE MOLECULAR SYSTEMS, INC.1N2026-01-014300 HACIENDA DRIVE PLEASANTON CA US 94588
30097311983009731198Roche Diagnostics Santa Clara1N2026-01-012881 Scott Blvd. Santa Clara CA US 95050
30113933763011393376ROCHE DIABETES CARE, INC.1Y2026-01-019115 Hague Road Indianapolis IN US 46250
30209175353020917535Roche Diagnostics (Suzhou) Ltd.1N2026-01-01No.259 Zhongyuan Road Suzhou Jiangsu CN 215028
30393216863039321686Roche Lumira Dx Stirling1N2026-01-01Manor Farm Business Park Manor Loan Stirling GB FK9 5QD
26277232627723Roche Operations, Ltd.1N2020-04-252875 Ponce By-Pass, PO Box 7085 Ponce PR US 00732

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
188561390026319P200014cobas® EZH2 Mutation TestOWD2020-06-18
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
188561570794295P160041COBAS CMVPAB2017-06-01
1997421570794295P160041COBAS CMVPAB2017-06-01
1997711570794295P160041COBAS CMVPAB2017-06-01
1995211641018977P160017MiniMed 670G SystemOZP2016-09-28
1997421098831314P150047cobas EGFR MUTATION TEST v2OWD2016-06-01
1997711098831314P150047cobas EGFR MUTATION TEST v2OWD2016-06-01
188561396788287P150015COBAS HCV TESTMZP2015-10-14
1997421396788287P150015COBAS HCV TESTMZP2015-10-14
1997711396788287P150015COBAS HCV TESTMZP2015-10-14
188561359806188P150014COBAS HBV TESTMKT2015-10-14
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
188562012092563P100020COBAS HPV TESTMAQ2011-04-19
1997422012092563P100020COBAS HPV TESTMAQ2011-04-19
1997712012092563P100020COBAS HPV TESTMAQ2011-04-19
1997421297247710P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TESTMZP2008-10-30
1997711297247710P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TESTMZP2008-10-30
1997421356533795P050028COBAS TAQMAN HBV TESTMKT2008-09-04
1997711356533795P050028COBAS TAQMAN HBV TESTMKT2008-09-04
188561082532934P000012COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0MZP2001-07-03
188561447406489K964506ROCHE COBAS AMPLICOR ANALYZERJJF1997-05-21
1997711447406489K964506ROCHE COBAS AMPLICOR ANALYZERJJF1997-05-21
188561965448203K961458AVL 9180 ELECTROLYTE ANALYZERJFP1996-06-12
188561448151041K951595ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESCGX1995-09-08
1997421670861153K253759cobas liat CT/NG/MG nucleic acid testQEP2026-05-15
1997711670861153K253759cobas liat CT/NG/MG nucleic acid testQEP2026-05-15
1997711710901118K243863Opulus™ Lymphoma PrecisionQIH2025-05-30
2185691710901118K243863Opulus™ 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
1997421834809751K243346cobas liat SARS-CoV-2 v2 nucleic acid testQWR2025-04-11
1997711834809751K243346cobas 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
188561261881002K240197cobas® liat CT/NG/MG nucleic acid testQEP2025-01-16
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
188561029264867K223591cobas® 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
1997711029264867K223591cobas® 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
188561163076532K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHCFR2022-09-16
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
1995211873962904K203711IWL2020 Blood Glucose Monitoring SystemNBW2022-05-06
1997421145259106K203220cobas BKVQLX2021-01-29
1997711145259106K203220cobas BKVQLX2021-01-29
188561419446411K202215cobas 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
1997711419446411K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQMI2020-09-02
188561886036373K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat SystemOCC2020-02-10
3097561070116898K190773Elecsys TSHJLW2019-04-16
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
1995211881244488K181131Accu-Chek Guide Me Blood Glucose Monitoring SystemNBW2018-12-13
188561113598221K173887cobas CT/NG for use on cobas 6800/8800 systemsLSL2018-03-21
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
188561040213773K171770cobas 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
1997711040213773K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZN2017-09-12
1997421568095057K163184cobas® CT/NG v2.0 TestLSL2017-02-09
1997711568095057K163184cobas® CT/NG v2.0 TestLSL2017-02-09
188561794300940K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerJLW2017-01-23
1995211692597719K160944ACCU-CHEK Guide Blood Glucose Monitoring SystemNBW2016-08-31
188561504629507K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemOCC2016-07-25
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
1995211038903404K150910ACCU-CHEK Connect Diabetes Management AppNDC2015-06-03
188561734084746K150617cobas HSV 1 and 2 TestOQO2015-06-01
1997421734084746K150617cobas HSV 1 and 2 TestOQO2015-06-01
1997711734084746K150617cobas HSV 1 and 2 TestOQO2015-06-01
188561573811548K142721cobas MRSA/SA TestNQX2014-12-17
1997421573811548K142721cobas MRSA/SA TestNQX2014-12-17
1997711573811548K142721cobas MRSA/SA TestNQX2014-12-17
188561738692858K142422cobas Cdiff TestOZN2015-05-20
1997421738692858K142422cobas Cdiff TestOZN2015-05-20
1997711738692858K142422cobas Cdiff TestOZN2015-05-20
1995211301228322K142089ACCU-CHEK AVIVA EXPERT SYSTEMLFR2014-12-17
1995211357083398K141929ACCU-CHEK CONNECT DIABETES MANAGEMENT APPNDC2015-03-16
1995211085570523K141867ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEMNBW2015-03-03
188561891892177K141338LIAT STREP A ASSAYPGX2014-11-04
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
1995211816833212K133862ACCU-CHEK AVIVA PLUS SYSTEMNBW2014-04-29
1995211796756956K133741ACCU-CHEK Performa Blood Glucose Monitoring SystemNBW2014-08-29
188561007000899K132270COBAS CT/NG V2.0 TESTLSL2013-12-02
1997421007000899K132270COBAS CT/NG V2.0 TESTLSL2013-12-02
1997711007000899K132270COBAS CT/NG V2.0 TESTLSL2013-12-02
1994191885803343K131029ACCU-CHEK AVIVA PLUS TEST STRIPNBW2013-08-09
1995211885803343K131029ACCU-CHEK AVIVA PLUS TEST STRIPNBW2013-08-09
1995211254619918K121679ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEMNBW2012-10-11
1995211424437190K113614ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEMNBW2013-02-12
1995211460102109K113137GLUCOSE TEST SYSTEMNBW2012-01-06
188561862878436K111387LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZEROCC2011-08-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW132022-05-06
LSL102018-03-21
QEP92026-05-15
QOF92025-07-31
MZP72022-11-04
OCC72020-02-10
OZN62017-09-12
OWD62015-05-07
QLX52021-01-29
PAB52017-06-01
MKT52015-10-14
NQX52014-12-17
JJF52003-12-17
QWR42025-04-11
LFR42014-12-17
QMI32020-09-02
OWD 32020-06-18
OQO32015-06-01
PGX32014-11-04
MAQ32011-04-19
OZZ22025-11-20
QIH22025-05-30
QQX22022-10-22
CFR22022-09-16
MAQ 22020-04-03
QIV22019-12-05
JLW22019-04-16
NDC22015-06-03
MKZ22012-01-24
NPR12018-01-12
OZP12016-09-28
LZG12012-07-17
CHL12012-05-14
DCF12010-09-09
KQO12010-04-02
MRZ12008-05-15
CIT12007-07-30
CIG12007-01-17
CEM12003-10-17
JJY12003-08-28

NDC#

Valium

Roche Laboratories Inc.

diazepam

Valium

Roche Laboratories Inc.

diazepam

Chemseptic

Rochester Midland Corporation

CHLOROXYLENOL

Hand San

Rochester Midland Corporation

ALCOHOL

PMA#

VITROS HBeAg Assays

2023-01-24

ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP090008 Supplement NumberS023 Date Received09/30/2022 Decision Date01/24/2023 Reclassified Date 12/22/2021 Product Code MZO  Advisory Committee Microbiology Supplement Typereal-time Proce...

cobas CMV

2022-12-14

ROCHE MOLECULAR SYSTEMS, INC.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP160041 Supplement NumberS035 Date Received05/31/2022 Decision Date12/14/2022 Product Code PAB  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplemen...

cobas® EZH2 Mutation Test

2022-11-29

Roche Molecular System, Inc.4300 Hacienda Drivepleasanton, CA 94588 PMA NumberP200014 Supplement NumberS004 Date Received10/18/2022 Decision Date11/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufact...

cobas® HPV

2022-11-14

Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP100020 Supplement NumberS054 Date Received10/21/2022 Decision Date11/14/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change -...

COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0

2022-11-14

Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP050028 Supplement NumberS086 Date Received10/21/2022 Decision Date11/14/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reaso...

cobas® BRAF V600 Mutation Test

2022-11-14

Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP110020 Supplement NumberS037 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason P...

COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test

2022-11-14

Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP110037 Supplement NumberS057 Date Received10/21/2022 Decision Date11/14/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reaso...

cobas® EGFR Mutation Test, v2.0

2022-11-14

ROCHE4300 Hacienda Drivepo Box 9002pleasanton, CA 94588 PMA NumberP120019 Supplement NumberS034 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Ma...

cobas® KRAS Mutation Test

2022-11-14

Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP140023 Supplement NumberS025 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason P...

Elecsys Anti-HBc II

2022-04-04

ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100032 Supplement NumberS021 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Label...

Elecsys Anti-HBc II

2022-04-04

ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100031 Supplement NumberS027 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Label...

Cobas HPV

2022-01-19

Roche Molecular Systems, Inc.

Cobas CMV

2022-01-19

ROCHE MOLECULAR SYSTEMS, INC.

cobas HCV

2021-06-02

Roche Molecular Systems, Inc.

cobas HBV

2021-06-02

Roche Molecular Systems, Inc.

cobas CMV

2021-06-02

ROCHE MOLECULAR SYSTEMS, INC.

cobas HPV

2021-06-02

Roche Molecular Systems, Inc.

cobas HBV

2020-12-10

Roche Molecular Systems, Inc.

cobas HCV

2020-12-10

Roche Molecular Systems, Inc.

cobas CMV

2020-12-10

ROCHE MOLECULAR SYSTEMS, INC.

cobas HPV

2020-12-10

Roche Molecular Systems, Inc.

200 records. Showing 1-40. Next

PMN#

Cobas HCV

2022-11-04

Roche Molecular Systems, Inc.

200 records. Showing 1-40. Next

Applications#

63 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next