Cobas CMV
ROCHE MOLECULAR SYSTEMS, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2243471 | 2243471 | ROCHE MOLECULAR SYSTEMS, INC. | 1 | N | 2027-01-01 | 1080 US Highway 202 South Branchburg NJ US 08876 |
| 3004141078 | 3004141078 | ROCHE MOLECULAR SYSTEMS, INC. | 1 | N | 2027-01-01 | 4300 HACIENDA DRIVE PLEASANTON CA US 94588 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 199742 | 1390026319 | P200014 | cobas® EZH2 Mutation Test | OWD | 2020-06-18 |
| 199771 | 1390026319 | P200014 | cobas® EZH2 Mutation Test | OWD | 2020-06-18 |
| 199742 | 1365813454 | P190028 | cobas HPV for use on the cobas 6800/8800 Systems | MAQ | 2020-04-03 |
| 199771 | 1365813454 | P190028 | cobas HPV for use on the cobas 6800/8800 Systems | MAQ | 2020-04-03 |
| 199742 | 1570794295 | P160041 | COBAS CMV | PAB | 2017-06-01 |
| 199771 | 1570794295 | P160041 | COBAS CMV | PAB | 2017-06-01 |
| 199742 | 1098831314 | P150047 | cobas EGFR MUTATION TEST v2 | OWD | 2016-06-01 |
| 199771 | 1098831314 | P150047 | cobas EGFR MUTATION TEST v2 | OWD | 2016-06-01 |
| 199742 | 1396788287 | P150015 | COBAS HCV TEST | MZP | 2015-10-14 |
| 199771 | 1396788287 | P150015 | COBAS HCV TEST | MZP | 2015-10-14 |
| 199742 | 1359806188 | P150014 | COBAS HBV TEST | MKT | 2015-10-14 |
| 199771 | 1359806188 | P150014 | COBAS HBV TEST | MKT | 2015-10-14 |
| 199742 | 1214322309 | P140023 | COBAS KRAS MUTATION TEST | OWD | 2015-05-07 |
| 199771 | 1214322309 | P140023 | COBAS KRAS MUTATION TEST | OWD | 2015-05-07 |
| 199742 | 1492829540 | P120019 | COBAS EGFR MUTATION TEST | OWD | 2013-05-14 |
| 199771 | 1492829540 | P120019 | COBAS EGFR MUTATION TEST | OWD | 2013-05-14 |
| 199742 | 1044053797 | P110037 | COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) | PAB | 2012-07-05 |
| 199771 | 1044053797 | P110037 | COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) | PAB | 2012-07-05 |
| 199742 | 1328295118 | P110020 | COBAS 4800 BRAF V600 MUTATION TEST | OWD | 2011-08-17 |
| 199771 | 1328295118 | P110020 | COBAS 4800 BRAF V600 MUTATION TEST | OWD | 2011-08-17 |
| 199742 | 2012092563 | P100020 | COBAS HPV TEST | MAQ | 2011-04-19 |
| 199771 | 2012092563 | P100020 | COBAS HPV TEST | MAQ | 2011-04-19 |
| 199771 | 1297247710 | P060030 | COBAS AMPLIPREP/COBAS TAQMAN HCV TEST | MZP | 2008-10-30 |
| 199742 | 1297247710 | P060030 | COBAS AMPLIPREP/COBAS TAQMAN HCV TEST | MZP | 2008-10-30 |
| 199742 | 1356533795 | P050028 | COBAS TAQMAN HBV TEST | MKT | 2008-09-04 |
| 199771 | 1356533795 | P050028 | COBAS TAQMAN HBV TEST | MKT | 2008-09-04 |
| 199771 | 1447406489 | K964506 | ROCHE COBAS AMPLICOR ANALYZER | JJF | 1997-05-21 |
| 199742 | 1894342244 | K260021 | cobas® BV/CV | PQA | 2026-07-16 |
| 199771 | 1894342244 | K260021 | cobas® BV/CV | PQA | 2026-07-16 |
| 199771 | 1670861153 | K253759 | cobas liat CT/NG/MG nucleic acid test | QEP | 2026-05-15 |
| 199742 | 1670861153 | K253759 | cobas liat CT/NG/MG nucleic acid test | QEP | 2026-05-15 |
| 199771 | 1710901118 | K243863 | Opulus™ Lymphoma Precision | QIH | 2025-05-30 |
| 199742 | 1774110026 | K243753 | cobas liat Bordetella panel nucleic acid test | OZZ | 2025-11-20 |
| 199771 | 1774110026 | K243753 | cobas liat Bordetella panel nucleic acid test | OZZ | 2025-11-20 |
| 199742 | 1547201773 | K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | QOF | 2025-07-31 |
| 199771 | 1547201773 | K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | QOF | 2025-07-31 |
| 199742 | 1448607452 | K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | QOF | 2025-04-25 |
| 199771 | 1448607452 | K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | QOF | 2025-04-25 |
| 199742 | 1572568139 | K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | QOF | 2025-04-25 |
| 199771 | 1572568139 | K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | QOF | 2025-04-25 |
| 199771 | 1834809751 | K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | QWR | 2025-04-11 |
| 199742 | 1834809751 | K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | QWR | 2025-04-11 |
| 199742 | 1611381171 | K240217 | cobas® liat CT/NG nucleic acid test | QEP | 2025-01-17 |
| 199771 | 1611381171 | K240217 | cobas® liat CT/NG nucleic acid test | QEP | 2025-01-17 |
| 199742 | 1261881002 | K240197 | cobas® liat CT/NG/MG nucleic acid test | QEP | 2025-01-16 |
| 199771 | 1261881002 | K240197 | cobas® liat CT/NG/MG nucleic acid test | QEP | 2025-01-16 |
| 199742 | 1640328398 | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | QWR | 2023-12-04 |
| 199771 | 1640328398 | K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | QWR | 2023-12-04 |
| 199771 | 1029264867 | K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | QOF | 2023-07-27 |
| 199742 | 1029264867 | K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | QOF | 2023-07-27 |
| 199742 | 1132001277 | K221007 | cobas HCV | MZP | 2022-11-04 |
| 199771 | 1132001277 | K221007 | cobas HCV | MZP | 2022-11-04 |
| 199742 | 1364073200 | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | QQX | 2022-10-22 |
| 199771 | 1364073200 | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | QQX | 2022-10-22 |
| 199771 | 1145259106 | K203220 | cobas BKV | QLX | 2021-01-29 |
| 199742 | 1145259106 | K203220 | cobas BKV | QLX | 2021-01-29 |
| 199771 | 1419446411 | K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | QMI | 2020-09-02 |
| 199742 | 1419446411 | K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | QMI | 2020-09-02 |
| 199742 | 1297293882 | K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit | QEP | 2019-05-22 |
| 199771 | 1297293882 | K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit | QEP | 2019-05-22 |
| 199742 | 1113598221 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems | LSL | 2018-03-21 |
| 199771 | 1113598221 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems | LSL | 2018-03-21 |
| 199742 | 1042701125 | K172913 | cobas Factor II and Factor V Test | NPR | 2018-01-12 |
| 199771 | 1040213773 | K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | OZN | 2017-09-12 |
| 199742 | 1040213773 | K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | OZN | 2017-09-12 |
| 199771 | 1568095057 | K163184 | cobas® CT/NG v2.0 Test | LSL | 2017-02-09 |
| 199742 | 1568095057 | K163184 | cobas® CT/NG v2.0 Test | LSL | 2017-02-09 |
| 199742 | 1504629507 | K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | OCC | 2016-07-25 |
| 199771 | 1504629507 | K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | OCC | 2016-07-25 |
| 199742 | 1734084746 | K150617 | cobas HSV 1 and 2 Test | OQO | 2015-06-01 |
| 199771 | 1734084746 | K150617 | cobas HSV 1 and 2 Test | OQO | 2015-06-01 |
| 199742 | 1573811548 | K142721 | cobas MRSA/SA Test | NQX | 2014-12-17 |
| 199771 | 1573811548 | K142721 | cobas MRSA/SA Test | NQX | 2014-12-17 |
| 199742 | 1738692858 | K142422 | cobas Cdiff Test | OZN | 2015-05-20 |
| 199771 | 1738692858 | K142422 | cobas Cdiff Test | OZN | 2015-05-20 |
| 199742 | 1891892177 | K141338 | LIAT STREP A ASSAY | PGX | 2014-11-04 |
| 199771 | 1891892177 | K141338 | LIAT STREP A ASSAY | PGX | 2014-11-04 |
| 199742 | 1832776303 | K140887 | COBAS CT/NG V2.0 TEST | LSL | 2014-05-05 |
| 199771 | 1832776303 | K140887 | COBAS CT/NG V2.0 TEST | LSL | 2014-05-05 |
| 199742 | 1007000899 | K132270 | COBAS CT/NG V2.0 TEST | LSL | 2013-12-02 |
| 199771 | 1007000899 | K132270 | COBAS CT/NG V2.0 TEST | LSL | 2013-12-02 |
| 199742 | 1862878436 | K111387 | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER | OCC | 2011-08-04 |
| 199771 | 1862878436 | K111387 | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER | OCC | 2011-08-04 |
| 199742 | 1594125537 | K110923 | COBAS 4800 CT / NG TEST | MKZ | 2012-01-24 |
| 199771 | 1594125537 | K110923 | COBAS 4800 CT / NG TEST | MKZ | 2012-01-24 |
| 199742 | 1931757536 | K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 | NQX | 2010-07-06 |
| 199771 | 1931757536 | K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 | NQX | 2010-07-06 |
| 199771 | 1528507523 | K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 | JJF | 2003-12-17 |
| 199771 | 1276700842 | K012966 | ROCHE COBAS TAQMAN ANALYZER | JJF | 2002-02-01 |
| 199742 | 1610484094 | DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | QLX | 2020-07-30 |
| 199771 | 1610484094 | DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | QLX | 2020-07-30 |
| 199771 | 1826967944 | DEN190016 | cobas vivoDx MRSA | QIV | 2019-12-05 |
| 199742 | 1826967944 | DEN190016 | cobas vivoDx MRSA | QIV | 2019-12-05 |
| 199742 | 1917596469 | BP190360 | |||
| 199771 | 1917596469 | BP190360 | |||
| 199742 | 1642967897 | BP150262 | |||
| 199771 | 1642967897 | BP150262 | |||
| 199742 | 1856699483 | BP050069 | |||
| 199771 | 1856699483 | BP050069 | |||
| 199771 | 1954295291 | BK251286 | |||
| 199742 | 1954295291 | BK251286 | |||
| 199771 | 1220507468 | BK251233 | |||
| 199742 | 1220507468 | BK251233 | |||
| 199771 | 1827747672 | BK140196 | |||
| 199771 | 1718067566 | BK140195 | |||
| 199742 | 1519980617 | ||||
| 199742 | 1647147344 | ||||
| 199742 | 1770588921 | ||||
| 199742 | 1102751767 | ||||
| 199771 | 1105418697 | ||||
| 199742 | 1105418697 | ||||
| 199742 | 1160335682 | ||||
| 199742 | 1171565720 | ||||
| 199742 | 1201101636 | ||||
| 199742 | 1220987228 | ||||
| 199742 | 1241756034 | ||||
| 199742 | 1273333367 | ||||
| 199771 | 1273639106 | ||||
| 199742 | 1273639106 | ||||
| 199742 | 1296806556 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QEP | 8 | 2026-05-15 |
| QOF | 8 | 2025-07-31 |
| LSL | 8 | 2018-03-21 |
| MZP | 6 | 2022-11-04 |
| OWD | 6 | 2015-05-07 |
| QWR | 4 | 2025-04-11 |
| QLX | 4 | 2021-01-29 |
| OZN | 4 | 2017-09-12 |
| PAB | 4 | 2017-06-01 |
| OCC | 4 | 2016-07-25 |
| MKT | 4 | 2015-10-14 |
| NQX | 4 | 2014-12-17 |
| JJF | 3 | 2003-12-17 |
| PQA | 2 | 2026-07-16 |
| OZZ | 2 | 2025-11-20 |
| QQX | 2 | 2022-10-22 |
| QMI | 2 | 2020-09-02 |
| OWD | 2 | 2020-06-18 |
| MAQ | 2 | 2020-04-03 |
| QIV | 2 | 2019-12-05 |
| OQO | 2 | 2015-06-01 |
| PGX | 2 | 2014-11-04 |
| MKZ | 2 | 2012-01-24 |
| MAQ | 2 | 2011-04-19 |
| QIH | 1 | 2025-05-30 |
| NPR | 1 | 2018-01-12 |
ROCHE MOLECULAR SYSTEMS, INC.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
ROCHE MOLECULAR SYSTEMS, INC.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
ROCHE MOLECULAR SYSTEMS, INC.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
ROCHE MOLECULAR SYSTEMS, INC.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
ROCHE MOLECULAR SYSTEMS, INC.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
ROCHE MOLECULAR SYSTEMS, INC.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE MOLECULAR SYSTEMS, INC.
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