SD Biosensor, Inc.

Address:C-4th&5th, 16, Deogyeong-daero,Suwon-si Gyeonggi,KR

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Filters

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

System, Test, Blood Glucose, Over The Counter (NBW) (7) Glucose Oxidase, Glucose (CGA) (6) Colorimetric Method, Triglycerides (JGY) (2) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (2) Ldl & Vldl Precipitation, Hdl (LBR) (2)

Premarket Exempt

Clear

SD GlucoNavii Blood Glucose Monitoring System - 00887473000009 Catalog Number :

Device Class : 2

Duns Number: 557812789

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

SD GlucoNavii Blood Glucose Monitoring System - 00887473000016 Catalog Number :

Device Class : 2

Duns Number: 557812789

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

SD GlucoNavii Blood Glucose Monitoring System - 00887473000108 Catalog Number :

Device Class : 2

Duns Number: 557812789

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

SD GlucoNavii Blood Glucose Test Strip - 00887473000122 Catalog Number :

Device Class :

Duns Number: 557812789

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 50

SD Glucose Control Solution - 00887473000139 Catalog Number :

Device Class : 2

Duns Number: 557812789

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 1

SD GlucoNavii Blood Glucose Test Strip - 00887473000160 Catalog Number :

Device Class :

Duns Number: 557812789

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 25

CURO L7 Analyzer - 08809319396161 Catalog Number :

Device Class : 1

Duns Number: 557812789

Premarket Exempt : No

Product Code : NBW, CHH, JGY, LBR

Prescription Use : No

Device Count : 1

CURO L7 Lipid Test Strip - Lipid Profile - 08809319396512 Catalog Number :

Device Class : 1

Duns Number: 557812789

Premarket Exempt : No

Product Code : CHH, JGY, LBR

Prescription Use : No

Device Count : 10

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