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, PROGESTERONE (JLS) (2) RADIOIMMUNOASSAY, ESTRADIOL (CHP) (2) RADIOIMMUNOASSAY, CORTICOSTERONE (CHA) (1) RADIOIMMUNOASSAY, ESTRONE (CGF) (1) RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE (CFL) (1) ENZYME LINKED IMMUNOABSORBENT ASSAY, MYCOPLASMA SPP. (LJZ) (1) SPERM, ANTIGEN, ANTISERUM, CONTROL (DFQ) (1) INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (1)

Premarket Exempt

No Yes

Clear

Micro-albumin ELISA - 00404847438819 Catalog Number : EIA-3881

Device Description : Micro-Albumin ELISA is a competitive test system for the quantitative measuremen Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JIR

Prescription Use : Yes

Device Count : 1

IGF-1 600 ELISA - 00404847441406 Catalog Number : EIA-4140

Device Description : The DRG IGF-1 600 ELISA is an enzyme immunoassay for the quantitative in vitro d The DRG IGF-1 600 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin-like Growth Factor 1, IGF-1, in serum.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CFL

Prescription Use : Yes

Device Count : 1

SALI-TUBES 500 - 00404847441574 Catalog Number : SLV-4157

Device Description : Sampling tubes for collection of saliva samples to be used in the DRG Salivary I Sampling tubes for collection of saliva samples to be used in the DRG Salivary Immunoassays

Device Class : 1

Duns Number: 317134468

Premarket Exempt : No

Product Code : JLS

Prescription Use : Yes

Device Count : 1

SALI-TUBES 100 - 00404847441581 Catalog Number : SLV-4158

Device Description : Sampling tubes for collection of saliva samples to be used in the DRG Salivary I Sampling tubes for collection of saliva samples to be used in the DRG Salivary Immunoassays

Device Class : 1

Duns Number: 317134468

Premarket Exempt : No

Product Code : JLS

Prescription Use : Yes

Device Count : 1

Corticosterone ELISA - 00404847441642 Catalog Number : EIA-4164

Device Description : The DRG Corticosterone ELISA is an enzyme immunoassay for the quantitative in vi The DRG Corticosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of corticosterone in serum or plasma (lithium heparin or citrate plasma).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CHA

Prescription Use : Yes

Device Count : 1

Estrone ELISA - 00404847441741 Catalog Number : EIA-4174

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CGF

Prescription Use : Yes

Device Count : 1

Salivary Estradiol ELISA - 00404847441888 Catalog Number : SLV-4188

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 Estradiol, an estrogenic steroid, in saliva.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CHP

Prescription Use : Yes

Device Count : 1

Sperm Antibody ELISA - 00404847442496 Catalog Number : EIA-4249

Device Description : The DRG Sperm Antibody (seminal plasma) ELISA is an enzyme immunoassay for the q The DRG Sperm Antibody (seminal plasma) ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of antibodies directed against human spermatozoa in seminal plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : DFQ

Prescription Use : Yes

Device Count : 1

Estradiol Sensitive ELISA - 00404847443998 Catalog Number : EIA-4399

Device Description : The DRG Estradiol sensitive ELISA is an enzyme immunoassay for the quantitative The DRG Estradiol sensitive ELISA is an enzyme 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

Mycoplasma hominis IgG ELISA - 00404847445596 Catalog Number : EIA-4559

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : LJZ

Prescription Use : Yes

Device Count : 1

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