510(k) K122514 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Sep 19, 2012 |
| Received | Aug 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122514
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2024 | Luminex Corporation Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test Open, Classified |
PAM | None listed |
| Dec 6, 2023 | Luminex Corporation Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 2 Open, Classified |
PAM | None listed |
| Oct 30, 2020 | Luminex Corporation Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018 Open, Classified |
OCC | None listed |
| Jun 15, 2020 | Luminex Corporation Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Ver Terminated |
PAM | None listed |
| Feb 11, 2019 | Luminex Corporation Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018
The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, m Terminated |
PAM | None listed |
| Nov 10, 2018 | Luminex Corporation VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits
(packaged as five-pack carriers)
Product Usage:
In vitro diagnostic test for the simultaneous detection and identification of potentially patho Terminated |
PAM | None listed |
| Sep 30, 2014 | Nanosphere, Inc. Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gr Terminated |
PAM | None listed |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous dete Terminated |
PAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.