510(k) K140083 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Jun 20, 2014 |
| Received | Jan 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2023 | Luminex Corporation Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 Open, Classified |
PCH | None listed |
| Aug 3, 2021 | Luminex Corporation Verigene EP Amplification Reagent Kit Test Open, Classified |
PCH | None listed |
| Mar 18, 2021 | Luminex Corporation VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology. Open, Classified |
PCH | None listed |
| Oct 30, 2020 | Luminex Corporation Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 Open, Classified |
OCC | None listed |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence marke Terminated |
PCH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.