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, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) (JKC) (2) TEST, FOLLICLE STIMULATING HORMONE (FSH), OVER THE COUNTER (NGA) (2) RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN (CFP) (1) CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE (NNK) (1) RADIOIMMUNOASSAY, PROGESTERONE (JLS) (1) RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) (CFT) (1) RADIOIMMUNOASSAY, LUTEINIZING HORMONE (CEP) (1) RADIOIMMUNOASSAY, ESTRADIOL (CHP) (1)

Premarket Exempt

Yes No

Clear

DHEA - 00404847453461 Catalog Number : HYE-5346

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JKC

Prescription Use : Yes

Device Count : 1

DHEA-S - 00404847453478 Catalog Number : HYE-5347

Device Description : The DRG:Hybrid-XL DHEA-S is an enzyme immunoassay for the quantitative in vitro The DRG:Hybrid-XL DHEA-S 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

Estradiol - 00404847453492 Catalog Number : HYE-5349

Device Description : The DRG:Hybrid-XL Estradiol is an enzyme immunoassay for the quantitative in vit The DRG:Hybrid-XL Estradiol 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

Free Estriol - 00404847453515 Catalog Number : HYE-5351

Device Description : The DRG:HYBRId-XL Free Estriol is an enzyme immunoassay for the quantitative in The DRG:HYBRId-XL Free Estriol is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol in serum.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : NGA

Prescription Use : Yes

Device Count : 1

FSH - 00404847453553 Catalog Number : HYE-5355

Device Description : The DRG:HYBRId-XL FSH is an enzyme immunoassay for the quantitative in vitro dia The DRG:HYBRId-XL FSH is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of follicle stimulating hormone in serum, heparin-, and EDTA-plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : NGA

Prescription Use : Yes

Device Count : 1

Insulin - 00404847453614 Catalog Number : HYE-5361

Device Description : The DRG:HYBRId-XL Insulin is an enzyme immunoassay for the quantitative in vitro The DRG:HYBRId-XL Insulin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (EDTA and Heparin).

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CFP

Prescription Use : Yes

Device Count : 1

LH - 00404847453621 Catalog Number : HYE-5362

Device Description : The DRG:Hybrid-XL LH is an enzyme immunoassay for the quantitative in vitro diag The DRG:Hybrid-XL LH is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of luteinizing hormone in serum and plasma.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 1

Progesterone - 00404847453683 Catalog Number : HYE-5368

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

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : JLS

Prescription Use : Yes

Device Count : 1

Prolactin - 00404847453690 Catalog Number : HYE-5369

Device Description : The DRG:Hybrid-XL Prolactin is an enzyme immunoassay for the quantitative in vit The DRG:Hybrid-XL Prolactin 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

Sample Preparation System (Stool) - 00404847456745 Catalog Number : EIA-5674

Device Description : A collection of devices intended to be used for the collection, preservation, an A collection of devices intended to be used for the collection, preservation, and transport of any type of clinical specimen from any body part.

Device Class : 1

Duns Number: 317134468

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : Yes

Device Count : 1

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