DRG Instruments Gesellschaft mit beschränkter Haftung

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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) (5) SYSTEM, TEST, RHEUMATOID FACTOR (DHR) (3) SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL (MID) (2)

Premarket Exempt

No Yes

Clear

Anti-SS-A (Ro) ELISA - 04048474035735 Catalog Number : EIA-3573

Device Description : Anti-SS-A (Ro) ELISA is a test system for the quantitative measurement of IgG cl Anti-SS-A (Ro) ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-A (52 kDa and 60 kDa) in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

Anti-SS-B ELISA - 04048474035766 Catalog Number : EIA-3576

Device Description : Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class a Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

Anti-Sm ELISA - 04048474035773 Catalog Number : EIA-3577

Device Description : Anti-Sm ELISA is a test system for the quantitative measurement of IgG class aut Anti-Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Sm in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

Anti-RNP/Sm ELISA - 04048474035780 Catalog Number : EIA-3578

Device Description : Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against RNP/Sm in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

Anti-Jo-1 ELISA - 04048474035810 Catalog Number : EIA-3581

Device Description : Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoa Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoantibodies against Jo-1 in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

Rheumatoid Factor IgG ELISA - 04048474035841 Catalog Number : EIA-3584

Device Description : Rheumatoid Factor IgG ELISA is a test system for the quantitative measurement of Rheumatoid Factor IgG ELISA is a test system for the quantitative measurement of IgG class rheumatoid factor in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Rheumatoid Factor IgM ELISA - 04048474035858 Catalog Number : EIA-3585

Device Description : Rheumatoid Factor IgM ELISA is a test system for the quantitative measurement of Rheumatoid Factor IgM ELISA is a test system for the quantitative measurement of IgM class rheumatoid factor in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Rheumatoid Factor IgA ELISA - 04048474035865 Catalog Number : EIA-3586

Device Description : Rheumatoid Factor IgA ELISA is a test system for the quantitative measurement of Rheumatoid Factor IgA ELISA is a test system for the quantitative measurement of IgA class autoantibodies against rheumatoid factor in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Anti-Cardiolipin IgG/IgM ELISA - 04048474035872 Catalog Number : EIA-3587

Device Description : Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measureme Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : MID

Prescription Use : Yes

Device Count : 1

Anti-Cardiolipin Screen ELISA - 04048474035896 Catalog Number : EIA-3589

Device Description : Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : MID

Prescription Use : Yes

Device Count : 1

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