510(k) K123197 ยท OZN C. Difficile Toxin Gene Amplification Assay
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
| Applicant | Nanosphere, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Dec 5, 2012 |
| Received | Oct 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2023 | Luminex Corporation VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 Open, Classified |
OZN | None listed |
| Oct 30, 2020 | Luminex Corporation Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022 Open, Classified |
OCC | None listed |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of Terminated |
OZN | None listed |
| Aug 8, 2014 | Nanosphere, Inc. Nanosphere Verigene
Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qua Terminated |
OZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.