NANOSPHERE, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrumentation For Clinical Multiplex Test Systems (NSU) (3) C.Difficile Toxin Gene Amplification Assay (OZN) (2) Real Time Nucleic Acid Amplification System (OOI) (2) Influenza A Virus Subtype Differentiation Nucleic Acid Assay (OEP) (1) Parainfluenza Multiplex Nucleic Acid Assay (OOU) (1) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (1) Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr (OMM) (1) Test, Factor Ii G20210a Mutations, Genomic Dna Pcr (NPR) (1) Bordetella Pertussis Dna Assay System (OZZ) (1) Test, Factor V Leiden Mutations, Genomic Dna Pcr (NPQ) (1) Human Metapneumovirus (Hmpv) Rna Assay System (OEM) (1) Influenza A And Influenza B Multiplex Nucleic Acid Assay (OZE) (1)

Premarket Exempt

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Clostridium difficile (CDF) Amplification Tray - 00857573006317 Catalog Number :

Device Description : The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m 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 toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).

Device Class : 2

Duns Number: 164757242

Premarket Exempt : No

Product Code : OZN

Prescription Use : Yes

Device Count : 1

Respiratory Pathogens Flex (RP Flex) Amplification Tray - 00857573006324 Catalog Number :

Device Description : The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.

Device Class : 2

Duns Number: 164757242

Premarket Exempt : No

Product Code : OZE, OEM, OCC, OEP, OZZ, OOU

Prescription Use : Yes

Device Count : 1

Hypercoagulation Panel (HC) Sample Buffer - 00857573006348 Catalog Number :

Device Description : The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.

Device Class : 2

Duns Number: 164757242

Premarket Exempt : No

Product Code : NPQ, OMM, NPR

Prescription Use : Yes

Device Count : 1

Clostridium difficile (CDF) Stool Sample Preparation Kit - 00857573006362 Catalog Number :

Device Class : 2

Duns Number: 164757242

Premarket Exempt : No

Product Code : OZN

Prescription Use : Yes

Device Count : 1

Verigene® Processor - 00857573006386 Catalog Number :

Device Description : The Verigene® Processor is an instrument which internalizes all of the functions The Verigene® Processor is an instrument which internalizes all of the functions required to process a Test Cartridge as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications.

Device Class : 2

Duns Number: 164757242

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

Verigene® Reader (Refurbished) - 00857573006393 Catalog Number :

Device Description : The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished)

Device Class : 2

Duns Number: 164757242

Premarket Exempt : No

Product Code : NSU, OOI

Prescription Use : Yes

Device Count : 1

Verigene® Processor SP (Refurbished) - 00857573006409 Catalog Number :

Device Description : The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished)

Device Class : 2

Duns Number: 164757242

Premarket Exempt : No

Product Code : NSU, OOI

Prescription Use : Yes

Device Count : 1

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