Company ยท US
Nanosphere, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2015. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 7 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 5 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 4 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 3 |
| NTI | Drug Metabolizing Enzyme Genotyping Systems | 2 |
| ODW | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System | 2 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 1 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 1 |
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2015 | K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Nanosphere, Inc. | OCC |
| Jun 20, 2014 | K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) Nanosphere, Inc. | PCH |
| Jan 8, 2014 | K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) Nanosphere, Inc. | PEN |
| Dec 5, 2012 | K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) Nanosphere, Inc. | OZN |
| Nov 6, 2012 | K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) Nanosphere, Inc. | NTI |
| Sep 19, 2012 | K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST Nanosphere, Inc. | PAM |
| Jun 26, 2012 | DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) Nanosphere, Inc. | PAM |
| Dec 16, 2011 | K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) Nanosphere, Inc. | NQX |
| Jan 10, 2011 | K103209 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) Nanosphere, Inc. | OCC |
| Nov 17, 2009 | K093337 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM Nanosphere, Inc. | OCC |
| Oct 21, 2009 | K092957 | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST Nanosphere, Inc. | OCC |
| Oct 9, 2009 | K092566 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) Nanosphere, Inc. | OCC |
| Jul 24, 2009 | K083294 | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST Nanosphere, Inc. | NUA |
| May 1, 2009 | K083088 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST Nanosphere, Inc. | OCC |
| Oct 11, 2007 | K070597 | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST Nanosphere, Inc. | NSU |
| Sep 17, 2007 | K070804 | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST Nanosphere, Inc. | ODW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2014 | Nanosphere, Inc. Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gr Terminated |
PEN | K132843 |
| 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 | K122514 |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence marke Terminated |
PCH | K140083 |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory viru Terminated |
OCC | K103209 |
| 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 | K122514 |
| 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 | K123197 |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous det Terminated |
PEN | K132843 |
| Aug 28, 2014 | Nanosphere, Inc. Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Terminated |
NTI | K120466 |
| Aug 14, 2014 | Nanosphere, Inc. Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, Terminated |
PEN | K132843 |
| 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 | K123197 |
| Aug 8, 2014 | Nanosphere, Inc. Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detecti Terminated |
PEN | K132843 |
| Mar 31, 2008 | Nanosphere, Inc. Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 6006 Terminated |
ODW | K070804 |