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

Immunoassay Method, Troponin Subunit (MMI) (4) Chromatographic Separation, Cpk Isoenzymes (JHT) (2) Myoglobin, Antigen, Antiserum, Control (DDR) (2)

Premarket Exempt

No Yes

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Nano-CheckerTM 710 Reader - 00895160002014 Catalog Number : NDT710

Device Description : Analyzer for Nano-CheckTM line of diagnostic products.

Device Class :

Duns Number: 126544316

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Nano-CheckTM AMI CK-MB - 00895160002021 Catalog Number : CD7142

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

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : JHT

Prescription Use : No

Device Count : 20

Nano-CheckTM PCT - 00895160002038 Catalog Number : CD7155

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, plasma or serum

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Nano-CheckTM CRP - 00895160002045 Catalog Number : CD7151

Device Description : In Vitro Diagnostic Test kit for the evaluation of CRP in human whole blood, ser In Vitro Diagnostic Test kit for the evaluation of CRP 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 hs-CRP - 00895160002052 Catalog Number : CD7152

Device Description : In Vitro Diagnostic Test kit for the evaluation of hs-CRP in human whole blood, In Vitro Diagnostic Test kit for the evaluation of hs-CRP in human whole blood, plasma or serum

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 20

Nano-CheckTM NT-proBNP - 00895160002069 Catalog Number : CD7154

Device Description : In Vitro Diagnostic Test kit for the determination of NT-proBNP (N-terminal pro- 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 AMI cTnI - 00895160002076 Catalog Number : CD7141

Device Description : In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human se In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 20

Nano-CheckTM AMI 2 in 1 - 00895160002083 Catalog Number : CD201S

Device Description : In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglob In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human serum and plasma

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : MMI, DDR

Prescription Use : No

Device Count : 20

Nano-CheckTM AMI 3 in 1 - 00895160002090 Catalog Number : CD301S

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 serum and plasma

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : MMI, JHT, DDR

Prescription Use : No

Device Count : 20

Nano-CheckTM AMI cTnI - 00895160002113 Catalog Number : CD7140

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

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 20

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