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

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM) (6) System, Test, Thyroid Autoantibody (JZO) (2) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1) System, Test, Anticardiolipin Immunological (MID) (1)

Premarket Exempt

Clear

ANTI-TG - 04260157080010 Catalog Number : ORG502

Device Description : ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AU

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : JZO

Prescription Use : Yes

Device Count : 1

ANTI-TPO - 04260157080027 Catalog Number : ORG503

Device Description : ANTI-TPO IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS A

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : JZO

Prescription Use : Yes

Device Count : 1

ENASCREEN - 04260157080034 Catalog Number : ORG506

Device Description : ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUT

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LLL

Prescription Use : Yes

Device Count : 1

ANTI-SS-A - 04260157080058 Catalog Number : ORG508

Device Description : ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

ANTI-SS-B - 04260157080065 Catalog Number : ORG509

Device Description : ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

ANTI-SM - 04260157080072 Catalog Number : ORG510

Device Description : ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AU

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

ANTI-RPN/SM - 04260157080089 Catalog Number : ORG511

Device Description : ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLAS

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

ANTI-SCI-70 - 04260157080096 Catalog Number : ORG512

Device Description : ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLAS

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

ANTI-JO-1 - 04260157080102 Catalog Number : ORG513

Device Description : ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

ANTI-CARDIOLIPIN IgG/IgM - 04260157080126 Catalog Number : ORG515

Device Description : Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measuremen

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : MID

Prescription Use : Yes

Device Count : 1

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