FDA.reportPublic FDA data

ROCHE DIAGNOSTICS OPERATIONS INC

Matched from indexed company URL: Roche Diagnostics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18232601823260ROCHE DIAGNOSTICS OPERATIONS INC1Y2026-01-019115 Hague Rd Indianapolis IN US 46250
30037951163003795116ROCHE DIAGNOSTICS INTERNATIONAL LTD.1N2026-01-01FORRENSTRASSE 2 ROTKREUZ Zug CH CH-6343
30097311983009731198Roche Diagnostics Santa Clara1N2026-01-012881 Scott Blvd. Santa Clara CA US 95050
30209175353020917535Roche Diagnostics (Suzhou) Ltd.1N2026-01-01No.259 Zhongyuan Road Suzhou Jiangsu CN 215028

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
188561390026319P200014cobas® EZH2 Mutation TestOWD2020-06-18
188561570794295P160041COBAS CMVPAB2017-06-01
188561396788287P150015COBAS HCV TESTMZP2015-10-14
188561359806188P150014COBAS HBV TESTMKT2015-10-14
188562012092563P100020COBAS HPV TESTMAQ2011-04-19
188561082532934P000012COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0MZP2001-07-03
188561447406489K964506ROCHE COBAS AMPLICOR ANALYZERJJF1997-05-21
188561965448203K961458AVL 9180 ELECTROLYTE ANALYZERJFP1996-06-12
188561448151041K951595ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESCGX1995-09-08
2185691710901118K243863Opulus™ Lymphoma PrecisionQIH2025-05-30
188561261881002K240197cobas® liat CT/NG/MG nucleic acid testQEP2025-01-16
188561029264867K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemQOF2023-07-27
188561163076532K220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHCFR2022-09-16
188561419446411K202215cobas 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
188561113598221K173887cobas CT/NG for use on cobas 6800/8800 systemsLSL2018-03-21
188561040213773K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZN2017-09-12
188561794300940K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerJLW2017-01-23
188561504629507K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemOCC2016-07-25
188561734084746K150617cobas HSV 1 and 2 TestOQO2015-06-01
188561573811548K142721cobas MRSA/SA TestNQX2014-12-17
188561738692858K142422cobas Cdiff TestOZN2015-05-20
188561891892177K141338LIAT STREP A ASSAYPGX2014-11-04
188561007000899K132270COBAS CT/NG V2.0 TESTLSL2013-12-02
188561862878436K111387LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZEROCC2011-08-04
188561889233019K111188COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS BCHL2012-05-14
188561585184467K100853COBAS 8000 MODULAR SERIES ANALYZERDCF2010-09-09
188561802366463K093555COBAS U411 TEST SYSTEMKQO2010-04-02
188561620053729K071211COBAS C 111 ANALYZERCIT2007-07-30
188561036950188K063744COBAS INTEGRA C 111CIG2007-01-17
3097561563874286K061048COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEMCFR2006-05-17
188561049161132K032453ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROLJJY2003-08-28
188561754090574K032311ROCHE DIAGNOSTICS OMNI S ANALYZERCEM2003-10-17
188561276700842K012966ROCHE COBAS TAQMAN ANALYZERJJF2002-02-01
188561610484094DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQLX2020-07-30
188561642967897BP150262
188561856699483BP050069
188561931216623BK160113
188561718067566BK140195
188561919902016
2185691176974879
188561273639106
188561317542115
3097561317542115
188561330393503
2185691393814812
188561393814812
188561514393019
188561557491714
2185691557491714
188561567751279
188561584436848
188561596702062
2185691683019601
188561865896836
2185691915203318
188561915203318
188561959539902

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCC32020-02-10
CFR22022-09-16
JLW22019-04-16
LSL22018-03-21
OZN22017-09-12
JJF22002-02-01
QIH12025-05-30
QEP12025-01-16
QOF12023-07-27
QMI12020-09-02
QLX12020-07-30
OWD 12020-06-18
PAB12017-06-01
MZP12015-10-14
MKT12015-10-14
OQO12015-06-01
NQX12014-12-17
PGX12014-11-04
CHL12012-05-14
MAQ12011-04-19
DCF12010-09-09
KQO12010-04-02
CIT12007-07-30
CIG12007-01-17
CEM12003-10-17
JJY12003-08-28
JFP11996-06-12
CGX11995-09-08

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...

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...

200 records. Showing 1-40. Next

PMN#

Ammonia II

2019-02-08

Roche Diagnostics Operations (RDO)

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next