NANO-DITECH CORPORATION

Address:259 Prospect Plains Rd Bldg K,Cranbury,NJ,08512,US

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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)

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Fluoroo-Check Heating Block - 00895160002649 Catalog Number : HB101

Device Description : The Fluoro-Check TM Heating Block is an anti-temperature preservation device des The Fluoro-Check TM Heating Block is an anti-temperature preservation device designed to obtain optimal temperature from reagents.The compact Digital-controlled Heating Block provides excellent space utilization and superior product quality.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Nano-CheckTM COVID-19 IgG/IgM Antibody Test - 00895160002663 Catalog Number :

Device Description : A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Fluoro-CheckTM CRP Test - 00895160002670 Catalog Number :

Device Description : A in vitro diagnostic test for the quantitative determination of C-reactive prot A in vitro diagnostic test for the quantitative determination of C-reactive protein as an aid in the detection and evaluation of infection, tissue injury, inflammation, and associated diseases.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Nano-Check TM Strep A Test - 00895160002687 Catalog Number :

Device Description : A lateral flow immunoassay for the qualitative detection of Strep A specific ca A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from human throat swabs specimen collected from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Nano-Check TM CRP plus Test - 00895160002694 Catalog Number :

Device Description : The rapid immunoassay for the quantitative determination of CRP (C-Reactive prot The rapid immunoassay for the quantitative determination of CRP (C-Reactive protein) in human whole blood, serum, or plasma specimens

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Fluoro-Check TM Strep A Test - 00895160002700 Catalog Number :

Device Description : Time resolved fluorescence immunoassay for the qualitative detection of Strep A Time resolved fluorescence immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from throat swabs specimen to aid in the diagnosis of Group A Streptococcal infection.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Nano-Check TM COVID-19 IgG Antibody Test - 00895160002724 Catalog Number :

Device Description : A in vitro diagnostic test for the qualitative detection of IgG antibody against A in vitro diagnostic test for the qualitative detection of IgG antibody against SARS-CoV-2 virus using human blood/serum/plasma samples.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Nano-Check TM COVID-19 Antigen Test - 00895160002786 Catalog Number :

Device Description : An in vitro diagnostic lateral flow immunoassay for the qualitative detection of An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Fluoro-Check TM COVID-19 Antigen Test - 00895160002793 Catalog Number :

Device Description : An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay fo An in vitro diagnostic, a time resolved fluorescence lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

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