Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)— 510(k) K143653
Substantially EquivalentNanosphere, Inc.
FDA 510(k) clearance K143653 for Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex), Substantially Equivalent on 2015-09-04. Applicant: Nanosphere, Inc.. Device class: 2.
Clearance details
- Applicant
- Nanosphere, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
Recent devices under product code OCC
view allMore clearances from Nanosphere, Inc.
view all- K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
- K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
- K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
- K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
- K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K143653
K-number listed on FDA's recall record- Z-1092-2022 — Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
- Z-2006-2021 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
- Z-0476-2021 — Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
- Z-0477-2021 — Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
- Z-0054-2021 — VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143653.
Data sourced from openFDA. This site is unofficial and independent of the FDA.