Medicalsystem Biotechnology Co., Ltd.

Address:No.299, Qiming South Road, Yinzhou District, 315104 Ningbo, China,Ningbo Zhejiang,CN

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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

Biuret (Colorimetric), Total Protein (CEK) (2) Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ) (2) Albumin, Antigen, Antiserum, Control (DCF) (1) Haptoglobin, Antigen, Antiserum, Control (DAD) (1) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (1) System, Test, Beta-2-Microglobulin Immunological (JZG) (1)

Premarket Exempt

Yes

Clear

Aspartate Aminotransferase Kit (Colorimetric Method ) - 06970291985154 Catalog Number :

Device Class : 2

Duns Number: 545261989

Premarket Exempt : Yes

Product Code : CIT

Prescription Use : Yes

Device Count : 1

Haptoglobin Kit (Immunoturbidimetric Method) - 06970291985161 Catalog Number :

Device Class : 2

Duns Number: 545261989

Premarket Exempt : Yes

Product Code : DAD

Prescription Use : No

Device Count : 1

Lactate Dehydrogenase Kit (Kinetic Method) - 06970291985178 Catalog Number :

Device Class : 2

Duns Number: 545261989

Premarket Exempt : Yes

Product Code : CFJ

Prescription Use : No

Device Count : 1

Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method) - 06970291985185 Catalog Number :

Device Class : 2

Duns Number: 545261989

Premarket Exempt : Yes

Product Code : CFJ

Prescription Use : No

Device Count : 1

Total Protein Kit (Biuret Method) - 06970291985192 Catalog Number :

Device Class : 2

Duns Number: 545261989

Premarket Exempt : Yes

Product Code : CEK

Prescription Use : No

Device Count : 1

Total Protein Kit (Biuret Method) (2-Part Reagents) - 06970291985208 Catalog Number :

Device Class : 2

Duns Number: 545261989

Premarket Exempt : Yes

Product Code : CEK

Prescription Use : No

Device Count : 1

β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method) - 06970291985215 Catalog Number :

Device Class : 2

Duns Number: 545261989

Premarket Exempt : Yes

Product Code : JZG

Prescription Use : No

Device Count : 1

Microalbuminuria Kit (Immunoturbidimetric Method) - 06970291985222 Catalog Number :

Device Class : 2

Duns Number: 545261989

Premarket Exempt : Yes

Product Code : DCF

Prescription Use : No

Device Count : 1

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