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

ANTISERA, CF, INFLUENZA VIRUS A, B, C (GNW) (2) ANTIGEN, B. PERTUSSIS (GOX) (1) ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS (LJM) (1) ANTISERUM, FLUORESCENT, C. DIPHTHERIAE (GOS) (1) ENZYME LINKED IMMUNOABSORBENT ASSAY, MYCOPLASMA SPP. (LJZ) (1) LACTOFERRIN, ANTIGEN, ANTISERUM, CONTROL (DEG) (1) RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN (CFP) (1) ANTIGEN, AGGLUTINATING, ECHINOCOCCUS SPP. (GPF) (1) RESPIRATORY SYNCYTIAL VIRUS - ELISA (MCE) (1)

Premarket Exempt

No Yes

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Bordetella pertussis IgG ELISA - 00404847434507 Catalog Number : EIA-3450

Device Description : The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for t The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma). This assay is intended for in vitro diagnostic use only.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GOX

Prescription Use : Yes

Device Count : 1

Echinococcus IgG ELISA - 00404847434729 Catalog Number : EIA-3472

Device Description : The DRG Echinococcus IgG Enzyme Immunoassay Kit provides materials for the quali The DRG Echinococcus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Echinococcus in human serum and plasma (EDTA-, heparin- or citrate plasma). This assay is intended for in vitro diagnostic use only.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GPF

Prescription Use : Yes

Device Count : 1

Mycoplasma pneumoniae IgG ELISA - 00404847434996 Catalog Number : EIA-3499

Device Description : The DRG Mycoplasma pneumoniae IgG Enzyme Immunoassay Kit provides materials for The DRG Mycoplasma pneumoniae IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Mycoplasma pneumoniae in human serum or plasma. This assay is intended for in vitro diagnostic use only.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : LJZ

Prescription Use : Yes

Device Count : 1

RSV IgG ELISA - 00404847435078 Catalog Number : EIA-3507

Device Description : The DRG RSV IgG Enzyme Immunoassay Kit provides materials for the qualitative an The DRG RSV IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Respiratory Syncytial Virus (RSV) in serum. This assay is intended for in vitro diagnostic use only.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : MCE

Prescription Use : Yes

Device Count : 1

Anti-Scl-70 ELISA - 00404847435801 Catalog Number : EIA-3580

Device Description : Anti-Scl-70 ELISA is a test system for the quantitative measurement of IgG class Anti-Scl-70 ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Scl-70 in human serum or plasma.

Device Class : 2

Duns Number: 317134468

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

Anti-Lactoferrin ELISA - 00404847436020 Catalog Number : EIA-3602

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : DEG

Prescription Use : Yes

Device Count : 1

Anti-Insulin ELISA - 00404847436082 Catalog Number : EIA-3608

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1

Influenza Virus A IgG ELISA - 00404847437935 Catalog Number : EIA-3793

Device Description : The Influenza Virus A IgG ELISA is intended for the qualitative determination of The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GNW

Prescription Use : Yes

Device Count : 1

Influenza Virus B IgG ELISA - 00404847437966 Catalog Number : EIA-3796

Device Description : The Influenza Virus B IgG ELISA is intended for the qualitative determination of The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GNW

Prescription Use : Yes

Device Count : 1

Cornybacterium diphtheriae toxin IgG ELISA - 00404847438246 Catalog Number : EIA-3824

Device Description : The Corynebacterium diphtheriae toxin IgG ELISA is intended for the quantitative The Corynebacterium diphtheriae toxin IgG ELISA is intended for the quantitative determination of IgG class antibodies against Corynebacterium diphtheriae toxin in human serum or plasma (citrate, heparin).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GOS

Prescription Use : Yes

Device Count : 1

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