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, LUTEINIZING HORMONE (CEP) (2) RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN (JKD) (2) RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE (CGJ) (1) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (1) RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) (CFT) (1) ACID, NITROUS AND NITROSONAPHTHOL, 5-HYDROXYINDOLE ACETIC ACID/SEROTONIN (CDA) (1) RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE (CDZ) (1) RADIOIMMUNOASSAY, 17-HYDROXYPROGESTERONE (JLX) (1)

Premarket Exempt

No Yes

Clear

FSH ELISA - 00404847412888 Catalog Number : EIA-1288

Device Description : The DRG FSH ELISA is an enzyme immunoassay for the quantitative in vitro diagnos The DRG FSH ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Follicle Stimulating Hormone (FSH) in serum.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CGJ

Prescription Use : Yes

Device Count : 1

LH-Serum ELISA - 00404847412895 Catalog Number : EIA-1289

Device Description : The DRG LH ELISA Kit is an enzyme immunoassay for the quantitative in vitro diag The DRG LH ELISA Kit is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of the Luteinizing Hormone (LH) in serum.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 1

LH-Urine ELISA - 00404847412901 Catalog Number : EIA-1290

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 1

Prolactin ELISA - 00404847412918 Catalog Number : EIA-1291

Device Description : The DRG Prolactin ELISA is an enzyme immunoassay for the quantitative in vitro d The DRG Prolactin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Prolactin in serum.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CFT

Prescription Use : Yes

Device Count : 1

17 OH-Progesterone ELISA - 00404847412925 Catalog Number : EIA-1292

Device Description : The DRG 17-OH Progesterone ELISA is an enzyme immunoassay for the quantitative i The DRG 17-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-a-OH Progesterone (17-a-OHP) in serum or plasma (EDTA, lithium heparin or citrate plasma).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JLX

Prescription Use : Yes

Device Count : 1

C-Peptide ELISA - 00404847412932 Catalog Number : EIA-1293

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : Yes

Device Count : 1

Serotonin ELISA - 00404847413007 Catalog Number : EIA-1300

Device Description : Enzyme immunoassay for the in-vitro diagnostic quantitative determination of Ser Enzyme immunoassay for the in-vitro diagnostic quantitative determination of Serotonin in human serum, plasma, platelets and urine.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CDA

Prescription Use : Yes

Device Count : 1

Testosterone ELISA - 00404847415599 Catalog Number : EIA-1559

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 1

Proinsulin ELISA - 00404847415605 Catalog Number : EIA-1560

Device Description : The DRG Proinsulin ELISA is an enzyme immunoassay for the quantitative in vitro The DRG Proinsulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Proinsulin (intact) in serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JKD

Prescription Use : Yes

Device Count : 1

Progesterone ELISA - 00404847415612 Catalog Number : EIA-1561

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

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