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

Clear

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

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

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

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,

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-

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

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

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

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

Device Class :

Duns Number: 126544316

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 20

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