ORGENTEC Diagnostika GmbH

Address:CARL-ZEISS-STRASSE 49-51,MAINZ Rhineland-Palatinate,DE

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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

Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control (LRM) (1)

Premarket Exempt

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ANTI-dsDNA - 04260157080683 Catalog Number : ORG604

Device Description : Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class Anti-dsDNA is an ELISA test system for the quantitative measurement of IgG class autoantibodies against double-stranded DNA in human serum or plasma. This product is intended for professional in vitro diagnostic use only.

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LRM

Prescription Use : Yes

Device Count : 1

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