Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of DiaSorinLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Nanosphere with 15 510(k) clearances and 11 device recalls. The most recent is a 510(k) clearance dated Sep 4, 2015: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex).
| Sep 4, 2015 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)K143653 · OCC | 510(k) clearances |
| Jun 20, 2014 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)K140083 · PCH | 510(k) clearances |
| Mar 18, 2014 | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 VerClass III · Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene | Device recalls |
| Jan 8, 2014 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)K132843 · PEN | 510(k) clearances |
| Oct 10, 2013 | The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of coClass II · Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed o | Device recalls |
| Oct 10, 2013 | The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to Class II · Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed o | Device recalls |
| Oct 10, 2013 | The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection ofClass II · Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed o | Device recalls |
| Oct 10, 2013 | The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative mClass II · Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed o | Device recalls |
| Oct 10, 2013 | The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, muClass II · Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed o | Device recalls |
| Jun 17, 2013 | Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests Class II · There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processi | Device recalls |
| Jun 17, 2013 | Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests Class II · There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processi | Device recalls |
| Dec 5, 2012 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)K123197 · OZN | 510(k) clearances |
| Nov 6, 2012 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)K120466 · NTI | 510(k) clearances |
| Sep 19, 2012 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTK122514 · PAM | 510(k) clearances |
| Jun 26, 2012 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)DEN120014 · PAM | 510(k) clearances |
| Dec 16, 2011 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)K112424 · NQX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
