MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.

Address:1018-1 Terasawaoka,INA Nagano,JP

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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

Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 (OEG) (2) Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) (NBO) (1)

Premarket Exempt

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DSG-1 & DSG-3 ELISA Test System - 04987506015942 Catalog Number : 7598US

Device Description : The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunos The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent assay for the determination of autoantibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in human serum. The DSG-1 & DSG-3 ELISA Test System is intended for in vitro diagnostic use as an aid in diagnosis of certain pemphigus diseases.https://www.mblintl.com/products/rg-m7593-d

Device Class : 2

Duns Number: 691688915

Premarket Exempt : No

Product Code : NBO

Prescription Use : No

Device Count : 1

MESACUP BP180 ELISA Kit - 04987506015959 Catalog Number : 7616US

Device Description : The MESACUP BP180 ELISA kit is a semi-quantitative enzyme-linked immunosorvent a The MESACUP BP180 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 180 antibodies in human serum. The MESACUP BP180 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings.https://www.mblintl.com/products/rg-m7612-d

Device Class : 2

Duns Number: 691688915

Premarket Exempt : No

Product Code : OEG

Prescription Use : No

Device Count : 1

MESACUP BP230 ELISA Kit - 04987506015966 Catalog Number : 7617US

Device Description : The MESACUP BP230 ELISA kit is a semi-quantitative enzyme-linked immunosorvent a The MESACUP BP230 ELISA kit is a semi-quantitative enzyme-linked immunosorvent assay (ELISA) for the detection of anti BP 230 antibodies in human serum. The MESACUP BP230 ELISA Kit is intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphgoid in conjunction with otehr laboratory and clinical findings.https://www.mblintl.com/products/rg-m7613-d

Device Class : 2

Duns Number: 691688915

Premarket Exempt : No

Product Code : OEG

Prescription Use : No

Device Count : 1

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