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

CHROMATOGRAPHIC/FLUOROMETRIC METHOD, CATECHOLAMINES (CHQ) (2) RADIOIMMUNOASSAY, 17-HYDROXYPROGESTERONE (JLX) (1) RADIOIMMUNOASSAY, ANDROSTENEDIONE (CIZ) (1) RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) (JKC) (1) RADIOIMMUNOASSAY, ESTRADIOL (CHP) (1) RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN (CFP) (1) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (1) ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 (GOD) (1) RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE (CDZ) (1)

Premarket Exempt

No Yes

Clear

Estradiol ELISA - 00404847426939 Catalog Number : EIA-2693

Device Description : The DRG Estradiol ELISA is an enzyme immunoassay for the quantitative in vitro d The DRG Estradiol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of estradiol in serum or plasma (EDTA, lithium heparin or citrate plasma).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : Yes

Device Count : 1

Metanephrine (Urine) ELISA - 00404847427486 Catalog Number : EIA-2748

Device Description : Enzyme immunoassay for the quantitative determination of metanephrine in human urine.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : Yes

Device Count : 1

Salivary Progesterone ELISA - 00404847429312 Catalog Number : SLV-2931

Device Description : Enzyme immunoassay for the in vitro diagnostic quantitative measurement of activ Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

Insulin ELISA - 00404847429350 Catalog Number : EIA-2935

Device Description : The DRG Insulin ELISA is an enzyme immunoassay for the quantitative in vitro dia The DRG Insulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (lithium heparin or EDTA plasma).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1

Salivary Testosterone ELISA - 00404847430134 Catalog Number : SLV-3013

Device Description : The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

Salivary 17-OH Progesterone ELISA - 00404847431407 Catalog Number : SLV-3140

Device Description : An enzyme immunoassay for the quantitative in vitro diagnostic measurement of ac An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : No

Product Code : JLX

Prescription Use : Yes

Device Count : 1

Catcombi ELISA - 00404847431759 Catalog Number : EIA-3175

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) and noradrenalin (norepinephrine) in human plasma and urine.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : Yes

Device Count : 1

Androstenedione ELISA - 00404847432657 Catalog Number : EIA-3265

Device Description : The DRG Androstenedione ELISA is an enzyme immunoassay for the quantitative in v The DRG Androstenedione ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum and EDTA plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CIZ

Prescription Use : Yes

Device Count : 1

DHEA ELISA - 00404847434156 Catalog Number : EIA-3415

Device Description : The DRG DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagno The DRG DHEA ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of [DHEA in serum or citrate plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : Yes

Device Count : 1

Adenovirus IgG ELISA - 00404847434460 Catalog Number : EIA-3446

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GOD

Prescription Use : Yes

Device Count : 1

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