NANO-DITECH CORPORATION

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

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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

Chromatographic Separation, Cpk Isoenzymes (JHT) (2) Immunoassay Method, Troponin Subunit (MMI) (2) Myoglobin, Antigen, Antiserum, Control (DDR) (2) Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies (NWY) (1) Visual, Pregnancy Hcg, Prescription Use (JHI) (1) Plasmodium Spp. Detection Reagents (OAX) (1) Dengue Serological Reagents (OSU) (1) Devices Detecting Influenza A, B, And C Virus Antigens (PSZ) (1)

Premarket Exempt

No Yes

Clear

Fluoro-CheckTM NT-proBNP - 00895160002434 Catalog Number : TF3152

Device Description : Fluorescence In Vitro Diagnostic Test kit for the determination of NT-proBNP (N- Fluorescence In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal pro-Brain natriuretic peptide) in human whole blood, serum or plasma

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Nano-CheckTM PCT plus - 00895160002441 Catalog Number : CD7156

Device Description : In Vitro Diagnostic Test kit for the determination of Procalcitonin in human who In Vitro Diagnostic Test kit for the determination of Procalcitonin in human whole blood, serum and plasma

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Nano-CheckTM 4 in 1 Test - 00895160002458 Catalog Number : CD402P

Device Description : In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : DDR, JHT, MMI

Prescription Use : No

Device Count : 20

Nano-CheckTM Malaria - 00895160002465 Catalog Number : MD8142

Device Description : An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich pr An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich protein 2) of Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) of Plasmodium vivax in human whole blood as an aid in the diagnosis of malaria infection.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : OAX

Prescription Use : No

Device Count : 20

Nano-CheckTM Dengue NS1 - 00895160002472 Catalog Number : MD8143

Device Description : An in vitro diagnostic test for the detection of Dengue NS1 protein in human who An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : OSU

Prescription Use : No

Device Count : 20

Nano-CheckTM Dengue IgM/IgG - 00895160002489 Catalog Number : MD8144

Device Description : An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in h An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : NWY

Prescription Use : No

Device Count : 20

Fluoro-CheckTM AMI 3 in 1 - 00895160002496 Catalog Number : TF3154

Device Description : In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : MMI, DDR, JHT

Prescription Use : No

Device Count : 20

Fluoro-CheckTM D-Dimer - 00895160002502 Catalog Number : TF3162

Device Description : In Vitro Diagnostic Test kit for the evaluation of D-Dimer concentration in huma In Vitro Diagnostic Test kit for the evaluation of D-Dimer concentration in human whole blood and plasma

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Fluoro-CheckTM beta-hCG - 00895160002519 Catalog Number : TF8146

Device Description : An in vitro diagnostic test for the determination of beta-Human chorionic gonado An in vitro diagnostic test for the determination of beta-Human chorionic gonadotropin in human whole blood, serum, and plasma.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 20

Fluoro-CheckTM Influenza A+B - 00895160002526 Catalog Number : TF8147

Device Description : An in vitro diagnostic test for the detection of influenza A and influenza B vir An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : PSZ

Prescription Use : No

Device Count : 20

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