ORGENTEC Diagnostika GmbH

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

Want to know more about this Organization? Request more information now!

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

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 ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) 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 : 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 ANTI-TPO IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROID PEROXIDASE (TPO) 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 : 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 ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUTOANTIBODIES AGAINST EXTRACABLE NUCLEAR ANTIGENS (ena) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGONSTIC USE ONLY.

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 ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-A (52 AND 60kDa) 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 : 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 ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) 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 : 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 ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM 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 : 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 ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM 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 : 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 ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SCL-70 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PRFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.

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 ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST JO-1 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 : 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 Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin 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 : MID

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 Next