Nanosphere, Inc.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 16
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2236-2014 | Class II | Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. | July 9, 2014 |
| Z-2170-2014 | Class II | Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result | April 17, 2014 |
| Z-2559-2014 | Class III | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 | March 18, 2014 |
| Z-2168-2014 | Class III | Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigen | October 16, 2013 |
| Z-2683-2014 | Class II | The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-res | October 10, 2013 |
| Z-2682-2014 | Class II | The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro di | October 10, 2013 |
| Z-2684-2014 | Class II | The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative | October 10, 2013 |
| Z-2681-2014 | Class II | The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-re | October 10, 2013 |
| Z-2685-2014 | Class II | The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simulta | October 10, 2013 |
| Z-2736-2014 | Class II | Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitativ | June 17, 2013 |
| Z-2735-2014 | Class II | Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitativ | June 17, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | September 4, 2015 |
| K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) | June 20, 2014 |
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | January 8, 2014 |
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | December 5, 2012 |
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | November 6, 2012 |
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | September 19, 2012 |
| DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) | June 26, 2012 |
| K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | December 16, 2011 |
| K103209 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) | January 10, 2011 |
| K093337 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM | November 17, 2009 |
| K092957 | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | October 21, 2009 |
| K092566 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) | October 9, 2009 |
| K083294 | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST | July 24, 2009 |
| K083088 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | May 1, 2009 |
| K070597 | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST | October 11, 2007 |
| K070804 | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST | September 17, 2007 |