Medical Device Manufacturer · US , Northbrook , IL

Nanosphere, Inc. - FDA 510(k) Cleared Devices

16 submissions · 15 cleared · Since 2007

Recent clearances: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex), VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP), VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

16

Total

15

Cleared

1

Denied

FDA 510(k) Regulatory Record - Nanosphere, Inc. Microbiology ✕

12 devices

1-12 of 12

Cleared Sep 04, 2015

Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)

Microbiology · 255d

Cleared Jun 20, 2014

VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)

Microbiology · 158d

Cleared Jan 08, 2014

VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

Microbiology · 120d

Cleared Dec 05, 2012

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

Microbiology · 55d

Cleared Sep 19, 2012

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

Microbiology · 33d

Not Cleared Jun 26, 2012

VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

DEN120014 · PAM

Microbiology · 11d

Cleared Dec 16, 2011

VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)

Microbiology · 115d

Cleared Jan 10, 2011

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)

Microbiology · 70d

Cleared Nov 17, 2009

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM

Microbiology · 22d

Cleared Oct 21, 2009

VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

Microbiology · 26d

Cleared Oct 09, 2009

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)

Microbiology · 50d

Cleared May 01, 2009

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

Microbiology · 197d