opgen.comAcuitas AMR Gene Panel
OpGen, Inc.
OPGEN, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007065145 | 3007065145 | OPGEN, INC. | 1 | N | 2020-04-25 | 708 Quince Orchard Rd Gaithersburg MD US 20878 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00812125010051 | Acuitas - Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit. | 301-869-9683 | technicalsupport@opgen.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 215057 | 1258501091 | K123418 | GRAM-NEGATIVE QUICKFISH BC | JSS | 2013-07-21 |
| 215057 | 1287191521 | K121991 | ENTEROCOCCUS QUICKFISH BC | OAH | 2013-01-07 |
| 215057 | 1621107583 | K113371 | STAPHYLOCOCCUS QUICKFISH BC | NXX | 2012-04-03 |
| 215057 | 1325769503 | K101558 | GNR TRAFFIC LIGHT PNA FISH | JSS | 2010-12-16 |
| 215057 | 1063942115 | K093024 | YEAST TRAFFIC LIGHT PNA FISH | NZS | 2010-07-15 |
| 215057 | 1480433722 | K092784 | C. ALBICANS/C. GLABRATA PNA FISH | NZS | 2010-03-12 |
| 215057 | 1055973615 | K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 | NXX | 2009-11-23 |
| 215057 | 1351411974 | K091827 | S. AUREUS PNA FISH | NXX | 2009-08-18 |
| 215057 | 1495668054 | K083074 | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT | OAH | 2009-07-24 |
| 215057 | 1049629671 | ||||
| 215057 | 1103312698 | ||||
| 215057 | 1210037226 | ||||
| 215057 | 1383086430 | ||||
| 215057 | 1426833718 | ||||
| 215057 | 1665486173 | ||||
| 215057 | 1669181237 | ||||
| 215057 | 1690256813 | ||||
| 215057 | 1740356084 | ||||
| 215057 | 1968414550 | ||||
| 215057 | 2026587385 | ||||
| 215057 | 2059397287 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Acuitas - QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
2023-04-28
Acuitas - QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
2021-10-25
Acuitas - Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
2023-04-28
Acuitas - A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
2023-04-28
Acuitas - Approximately 700 µl Master Mix in 1.5 ml screwcap tube with blue cap; component of KT03U01-2 Acuitas AMR Gene Panel Reagent Kit.
2021-10-25
Acuitas - A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
2021-10-06
Acuitas - PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.
2023-04-28
Acuitas - Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate contains four (4) panels of twenty-four (24) dried down, multiplexed PCR assays for use with the Acuitas AMR Gene Panel.
2023-04-28
Acuitas - PCR Plate Seal Package component of KT03U01-1 Acuitas AMR Gene Panel PCR Assay Plate Kit consisting of two (2) PCR Plate Seals pouched in a labeled clear plastic bag.
2023-04-28
Acuitas - Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gene Panel assay. A 2 mL screwcap tube containing approximately 90,000 CFU of Bacillus subtilis (ATCC 31028) dried down from a solution.
2023-04-28
Acuitas - QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
2023-04-28
Acuitas - Sealed, 96-well plate in Mylar Pouch. Each sealed and pouched Acuitas AMR Gene Panel PCR Plate contains four (4) panels of twenty-four (24) dried down, multiplexed PCR assays for use with the Acuitas AMR Gene Panel.
2021-10-25
Acuitas - PCR Plate Seal Package component of KT03U01-1 Acuitas AMR Gene Panel PCR Assay Plate Kit consisting of two (2) PCR Plate Seals pouched in a labeled clear plastic bag.
2021-10-25
Acuitas - Assay Control is used to monitor extraction efficiency and PCR inhibition in the Acuitas AMR Gene Panel assay. A 2 mL screwcap tube containing approximately 90,000 CFU of Bacillus subtilis (ATCC 31028) dried down from a solution.
2021-10-25
Acuitas - Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
2023-04-28
Acuitas - QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
2021-10-25
Acuitas - Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
2021-10-25
Acuitas - PCR Assay Plate Kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) PCR Assay Plates and one (1) PCR Plate Seal Package in a labeled, white, reverse tuck box.
2021-10-06