Light Diagnostics VZV DFA Reagent - VZV DFA Reagent
2020-04-03
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009432145 | 2244894 | EMD MILLIPORE CORPORATION | 1 | Y | 2026-01-01 | 400 Summit Drive Burlington MA US 01803 |
| 2028340 | 2024094 | EMD MILLIPORE CORPORATION | 1 | N | 2020-04-25 | 28820 SINGLE OAK DR. TEMECULA CA US 92590 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04053252270239 | Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent - SimulFluor® Flu A / Flu B Reagent | 1 (951) 676-8080 | R128863@merckgroup.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 1177 | 1644064898 | K992252 | LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 | LYF | 1999-08-10 |
| 1177 | 1601479138 | K991880 | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | GQN | 1999-11-09 |
| 1177 | 1405060325 | K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | GQW | 1999-10-19 |
| 1177 | 1928859300 | K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | GNW | 1998-04-08 |
| 1177 | 1281220719 | K972975 | LIGHT DIAGNOSTICS RABIES DFA REAGENT | GOI | 1998-12-22 |
| 1177 | 1538408552 | K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | LIN | 1996-06-07 |
| 1177 | 1545580300 | K951799 | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | GQX | 1996-03-20 |
| 1177 | 1597313396 | K940473 | ENTEROVIRUS 71 MONOCLONAL ANTIBODY | GOE | 1995-09-12 |
| 1177 | 2038693699 | K940472 | COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY | GNM | 1995-09-08 |
| 1177 | 1790320852 | K940471 | COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES | GNM | 1995-09-08 |
| 1177 | 1090654420 | K940363 | ENTEROVIRUS 70 MONCLONAL ANTIBODY | GOE | 1995-09-08 |
| 1177 | 1940450212 | K940034 | POLIOVIRUS 2 MONOCLONAL ANTIBODY | GOE | 1995-09-12 |
| 1177 | 1281145116 | K940027 | ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES | GOE | 1995-09-12 |
| 1177 | 1568638774 | K940026 | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES | GOE | 1995-09-12 |
| 1177 | 1936194322 | K940018 | POLIOVIRUS 1 MONOCLONAL ANTIBODY | GOE | 1995-09-08 |
| 1177 | 1911951690 | K940017 | POLIOVIRUS 3 MONOCLONAL ANTIBODY | GOE | 1995-09-12 |
| 1177 | 1871144916 | K936254 | COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY | GNM | 1995-09-08 |
| 1177 | 1545461744 | K936253 | COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY | GNM | 1995-09-08 |
| 1177 | 1140260780 | K936252 | COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY | GNM | 1995-09-08 |
| 1177 | 1917046568 | K936251 | COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY | GNM | 1995-09-08 |
| 1177 | 1128103046 | K936145 | COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY | GNM | 1995-09-08 |
| 1177 | 1232019818 | K936089 | COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY | GNM | 1995-09-08 |
| 1177 | 1342293507 | K936073 | ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS | GNM | 1995-09-08 |
| 1177 | 1384600231 | K935809 | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY | GQH | 1994-05-05 |
| 1177 | 1942123949 | K922801 | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY | GNY | 1993-01-06 |
| 1177 | 1295018933 | K093815 | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 | OMG | 2010-03-12 |
| 1177 | 1861412678 | K081527 | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT | GQL | 2009-04-01 |
| 142901 | 1006995333 | ||||
| 1177 | 1046954460 | ||||
| 1177 | 1060871773 | ||||
| 1177 | 1129273456 | ||||
| 142901 | 1132068346 | ||||
| 142901 | 1136433533 | ||||
| 142901 | 1164015490 | ||||
| 1177 | 1257131615 | ||||
| 142901 | 1277844076 | ||||
| 1177 | 1279027434 | ||||
| 142901 | 1300435845 | ||||
| 142901 | 1323276931 | ||||
| 142901 | 1396544908 | ||||
| 1177 | 1434998818 | ||||
| 1177 | 1455870649 | ||||
| 142901 | 1457289368 | ||||
| 1177 | 1458780535 | ||||
| 1177 | 1466069575 | ||||
| 142901 | 1467682542 | ||||
| 1177 | 1516654957 | ||||
| 142901 | 1562884308 | ||||
| 142901 | 1601923136 | ||||
| 142901 | 1665258238 | ||||
| 1177 | 1730255274 | ||||
| 1177 | 1820302798 | ||||
| 142901 | 1829754247 | ||||
| 1177 | 1881380422 | ||||
| 1177 | 1910425760 | ||||
| 1177 | 1913783356 | ||||
| 142901 | 1930012798 | ||||
| 1177 | 1951570772 | ||||
| 142901 | 1985825696 | ||||
| 142901 | 1990728566 | ||||
| 1177 | 2013965154 | ||||
| 142901 | 1022537357 | ||||
| 142901 | 1090457596 | ||||
| 142901 | 1096387897 | ||||
| 142901 | 1105428247 | ||||
| 142901 | 1141893120 | ||||
| 142901 | 1155365735 | ||||
| 142901 | 1161445595 | ||||
| 142901 | 1222403517 | ||||
| 142901 | 1328515828 | ||||
| 142901 | 1383181499 | ||||
| 142901 | 1429669809 | ||||
| 142901 | 1430843919 | ||||
| 142901 | 1446192651 | ||||
| 142901 | 1515620072 | ||||
| 142901 | 1536021948 | ||||
| 142901 | 1537791319 | ||||
| 142901 | 1609087398 | ||||
| 142901 | 1611232152 | ||||
| 142901 | 1628437476 | ||||
| 142901 | 1665140581 | ||||
| 142901 | 1684870101 | ||||
| 142901 | 1695420652 | ||||
| 142901 | 1840108321 | ||||
| 142901 | 1841490427 | ||||
| 142901 | 1881380422 | ||||
| 142901 | 1910425760 | ||||
| 142901 | 1944605305 | ||||
| 142901 | 1970359387 | ||||
| 142901 | 2032494461 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GNM | 9 | 1995-09-08 |
| GOE | 7 | 1995-09-12 |
| OMG | 1 | 2010-03-12 |
| GQL | 1 | 2009-04-01 |
| GQN | 1 | 1999-11-09 |
| GQW | 1 | 1999-10-19 |
| LYF | 1 | 1999-08-10 |
| GOI | 1 | 1998-12-22 |
| GNW | 1 | 1998-04-08 |
| LIN | 1 | 1996-06-07 |
| GQX | 1 | 1996-03-20 |
| GQH | 1 | 1994-05-05 |
| GNY | 1 | 1993-01-06 |
2020-04-03
2016-09-23
2016-09-09
2016-09-26
2022-06-28
2022-12-01
2022-12-01
2022-12-01
2022-12-01
2022-12-01
2022-12-01
2022-12-01
2022-12-01
2022-12-01
2022-12-01
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-30
2022-11-29
2022-11-29
2022-11-29