ORGENTEC Diagnostika GmbH

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

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- Catalog Number : ORG515A

Device Description : Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA 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

Device Description : Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgG, IgM and IgA 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

- Catalog Number : ORG518

Device Description : Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class a Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) 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 : MOB

Prescription Use : Yes

Device Count : 1

- Catalog Number : ORG519

Device Description : Anti-MPO is an ELISA test system for the quantitative measurement of IgG class a Anti-MPO is an ELISA test system for the quantitative measurement of IgG class autoantibodies against myeloperoxidase (MPO) 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 : MOB

Prescription Use : Yes

Device Count : 1

- Catalog Number : ORG522A

Device Description : Rheumatoid Factor IgA is an ELISA test system for the quantitative measurement o Rheumatoid Factor IgA is an ELISA test system for the quantitative measurement of IgA class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

- Catalog Number : ORG522G

Device Description : Rheumatoid Factor IgG is an ELISA test system for the quantitative measurement o Rheumatoid Factor IgG is an ELISA test system for the quantitative measurement of IgG class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

- Catalog Number : ORG522M

Device Description : Rheumatoid Factor IgM is an ELISA test system for the quantitative measurement o Rheumatoid Factor IgM is an ELISA test system for the quantitative measurement of IgM class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Device Description : Rheumatoid Factor Total is an ELISA test system for the quantitative measurement Rheumatoid Factor Total is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

- Catalog Number : ORG548

Device Description : Anti-MCV® is an ELISA test system for the qualitative and semi-quantitative meas Anti-MCV® is an ELISA test system for the qualitative and semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma. This product is intended for professional in vitro diagnostic use as an aid in the diagnosis of Rheumatoid Arthritis in conjuction with other laboratory and clinical findings.

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : OQZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : ORG600

Device Description : ANA Detect is an ELISA test system for the qualitative measurement of IgG class ANA Detect is an ELISA test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of certain systematic rheumatic diseases.

Device Class : 2

Duns Number: 328133103

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1