LSI MEDIENCE CORPORATION

Address:13-4, Uchikanda 1-chome,Chiyoda-ku Tokyo,JP

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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

Fibrin Split Products (GHH) (1) Fluorometric Method, Cpk Or Isoenzymes (JHX) (1) Immunoassay Method, Troponin Subunit (MMI) (1) Myoglobin, Antigen, Antiserum, Control (DDR) (1) System, Test, C-Reactive Protein (DCN) (1) Test,Natriuretic Peptide (NBC) (1)

Premarket Exempt

Clear

PATHFAST cTnI-II - 04987595301131 Catalog Number :

Device Class : 2

Duns Number: 691093090

Premarket Exempt : No

Product Code : MMI

Prescription Use : No

Device Count : 1

PATHFAST Myo-II - 04987595301230 Catalog Number :

Device Class : 2

Duns Number: 691093090

Premarket Exempt : No

Product Code : DDR

Prescription Use : No

Device Count : 1

PATHFAST CK-MB-II - 04987595301339 Catalog Number :

Device Class : 2

Duns Number: 691093090

Premarket Exempt : No

Product Code : JHX

Prescription Use : No

Device Count : 1

PATHFAST D-Dimer - 04987595301537 Catalog Number :

Device Class : 2

Duns Number: 691093090

Premarket Exempt : No

Product Code : GHH

Prescription Use : No

Device Count : 1

PATHFAST NTproBNP - 04987595301636 Catalog Number :

Device Class : 2

Duns Number: 691093090

Premarket Exempt : No

Product Code : NBC

Prescription Use : No

Device Count : 1

PATHFAST hsCRP - 04987595301742 Catalog Number :

Device Class : 2

Duns Number: 691093090

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

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