DRG Instruments Gesellschaft mit beschränkter Haftung

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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, 17-HYDROXYPROGESTERONE (JLX) (2) ANTISERUM, CF, Q FEVER (GPR) (2) RADIOIMMUNOASSAY, ANDROSTENEDIONE (CIZ) (2) RADIOIMMUNOASSAY, ESTRADIOL (CHP) (1) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (1) COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE (JJQ) (1) ENZYME LINKED IMMUNOABSORBENT ASSAY, MYCOPLASMA SPP. (LJZ) (1)

Premarket Exempt

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Ureaplasma urealyticum IgG ELISA - 00404847446234 Catalog Number : EIA-4623

Device Description : The DRG Ureaplasma urealyticum IgG Enzyme Immunoassay Kit provides materials for The DRG Ureaplasma urealyticum IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Ureaplasma urealyticum in serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : LJZ

Prescription Use : Yes

Device Count : 1

Progesterone (serum) ELISA - 00404847446630 Catalog Number : CLA-4663

Device Description : The DRG Progesterone Chemiluminescence Immunoassay Kit provides materials for th The DRG Progesterone Chemiluminescence Immunoassay Kit provides materials for the quantitative determination of Progesterone in serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

Estradiol (serum) ELISA - 00404847446647 Catalog Number : CLA-4664

Device Description : The DRG Estradiol CLIA is a Chemiluminescence Immunoassay for the quantitative i The DRG Estradiol CLIA is a Chemiluminescence Immunoassay for the quantitative in vitro diagnostic measurement of Estradiol in serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : Yes

Device Count : 1

Progesterone, 17-a-OH ELISA - 00404847446654 Catalog Number : CLA-4665

Device Description : The DRG 17-a-OH Progesterone Chemiluminescence Immunoassay Kit provides material The DRG 17-a-OH Progesterone Chemiluminescence Immunoassay Kit provides materials for the quantitative determination of 17-a-OH Progesterone in serum.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JLX

Prescription Use : Yes

Device Count : 1

Androstenedione ELISA - 00404847450507 Catalog Number : EIA-5050

Device Description : Competitive immunoenzymatic colorimetric method for quantitative determination o Competitive immunoenzymatic colorimetric method for quantitative determination of Androstenedione concentration in human serum or plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CIZ

Prescription Use : Yes

Device Count : 1

Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA - 00404847451887 Catalog Number : EIA-5188

Device Description : The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitativ The Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 1 in human serum or plasma (citrate, heparin).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GPR

Prescription Use : Yes

Device Count : 1

Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA - 00404847451894 Catalog Number : EIA-5189

Device Description : The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitativ The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : GPR

Prescription Use : Yes

Device Count : 1

DRG:HYBRiD.XL® - 00404847452525 Catalog Number : HYB-5252

Device Description : The DRG:HYBRiD-XL® is a fully automated random access analyzer.The innovative te The DRG:HYBRiD-XL® is a fully automated random access analyzer.The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples.The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

Progesterone (17-a-OH Progesterone) - 00404847453331 Catalog Number : HYE-5333

Device Description : The DRG:Hybrid-XL 17-OH Progesterone is an enzyme immunoassay for the quantitat The DRG:Hybrid-XL 17-OH Progesterone is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-a-OH Progesterone (17-OH Progesterone or 17OHP) in serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JLX

Prescription Use : Yes

Device Count : 1

Androstenedione - 00404847453393 Catalog Number : HYE-5339

Device Description : The DRG:Hybrid-XL Androstenedione is an enzyme immunoassay for the quantitative The DRG:Hybrid-XL Androstenedione is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CIZ

Prescription Use : Yes

Device Count : 1

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