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

RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE (CFL) (2) ANTIGEN, CF, ASPERGILLUS SPP. (JWT) (1) ANTIGENS, CF (INCLUDING CF CONTROL), POLIOVIRUS 1-3 (GOH) (1) ANTISERUM, FLUORESCENT, C. DIPHTHERIAE (GOS) (1) CHROMATOGRAPHIC/FLUOROMETRIC METHOD, CATECHOLAMINES (CHQ) (1) RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) (JKC) (1) RADIOIMMUNOASSAY, ESTRIOL (CGI) (1) ACID, NITROUS AND NITROSONAPHTHOL, 5-HYDROXYINDOLE ACETIC ACID/SEROTONIN (CDA) (1) SPERM, ANTIGEN, ANTISERUM, CONTROL (DFQ) (1)

Premarket Exempt

No Yes

Clear

DHEA-S ELISA - 00404847415629 Catalog Number : EIA-1562

Device Description : The DRG DHEA S ELISA is an enzyme immunoassay for the quantitative in vitro diag The DRG DHEA S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : Yes

Device Count : 1

Free Estriol ELISA - 00404847416121 Catalog Number : EIA-1612

Device Description : The DRG Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitr The DRG Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol (unconjugated estriol) in serum during the second half of pregnancy.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CGI

Prescription Use : Yes

Device Count : 1

Sperm Antibody ELISA - 00404847418262 Catalog Number : EIA-1826

Device Description : The DRG Sperm Antibody ELISA is an enzyme immunoassay for the quantitative in vi The DRG Sperm Antibody ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of antibodies directed against human spermatozoa in serum.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : DFQ

Prescription Use : Yes

Device Count : 1

TGF-Beta 1 ELISA - 00404847418644 Catalog Number : EIA-1864

Device Description : The DRG TGF-ß1 ELISA is an enzyme immunoassay for the quantitative in vitro diag The DRG TGF-ß1 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of TGF-ß1 in serum and cell culture supernatant.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CFL

Prescription Use : Yes

Device Count : 1

5-HIAA ELISA - 00404847418866 Catalog Number : EIA-1886

Device Description : Enzyme immunoassay for the in vitro diagnostic quantitative determination of 5-H Enzyme immunoassay for the in vitro diagnostic quantitative determination of 5-HIAA in human urine.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CDA

Prescription Use : Yes

Device Count : 1

Adrenaline ELISA - 00404847419085 Catalog Number : EIA-1908

Device Description : Manual and automated enzyme immunoassay for the in vitro diagnostic quantitative Manual and automated enzyme immunoassay for the in vitro diagnostic quantitative determination of adrenalin (epinephrine) in human plasma and urine.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : Yes

Device Count : 1

TGF-Beta 2 ELISA - 00404847423969 Catalog Number : EIA-2396

Device Description : The DRG TGF-ß2 ELISA is an enzyme immunoassay for the quantitative in vitro diag The DRG TGF-ß2 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of TGF-ß2 in serum, plasma and cell culture supernatant.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CFL

Prescription Use : Yes

Device Count : 1

Aspergillus fumigatus IgG ELISA - 00404847425017 Catalog Number : EIA-2501

Device Description : Enzyme immunassay for the qualitative and quantitative determination of IgG anti Enzyme immunassay for the qualitative and quantitative determination of IgG antibodies against Aspergillus fumigatus in human serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JWT

Prescription Use : Yes

Device Count : 1

Diphtheria IgG ELISA - 00404847425147 Catalog Number : EIA-2514

Device Description : Enzyme immunoassay for the quantitative determination of IgG class antibodies ag Enzyme immunoassay for the quantitative determination of IgG class antibodies against Diphtheria in human serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GOS

Prescription Use : Yes

Device Count : 1

Poliomyelitis ELISA - 00404847425581 Catalog Number : EIA-2558

Device Description : The Poliomyelitis Virus IgG ELISA has been designed for the detection and the qu The Poliomyelitis Virus IgG ELISA has been designed for the detection and the quantitative determination of specific IgG antibodies against Polio Serotypes 1 and 3 in serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GOH

Prescription Use : Yes

Device Count : 1

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