510(k) K132843 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Jan 8, 2014 |
| Received | Sep 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132843
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2025 | Luminex Corporation VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test Completed |
PEN | None listed |
| Feb 15, 2022 | Luminex Corporation VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 Open, Classified |
PEP | None listed |
| Oct 30, 2020 | Luminex Corporation Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021 Open, Classified |
OCC | None listed |
| Jun 15, 2020 | Luminex Corporation Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Ver Terminated |
PEN | None listed |
| Sep 30, 2014 | Nanosphere, Inc. Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gr Terminated |
PEN | None listed |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous det Terminated |
PEN | None listed |
| Aug 14, 2014 | Nanosphere, Inc. Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, Terminated |
PEN | None listed |
| Aug 8, 2014 | Nanosphere, Inc. Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detecti Terminated |
PEN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.