DRG International Inc

Address:841 Mountain Ave,Springfield,NJ,07081,US

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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

ENZYMATIC METHODS, GALACTOSE (JIA) (4) RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE (JLW) (2) Enzyme immunoassay, non-radiolabeled, total thyroxine (KLI) (1) RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE (CDP) (1) TEST, FOLLICLE STIMULATING HORMONE (FSH), OVER THE COUNTER (NGA) (1) Visual, pregnancy hCG, prescription use (JHI) (1)

Premarket Exempt

No Yes

Clear

Neonatal TSH ELISA - 00840239014832 Catalog Number : EIA-1483

Device Description : The DRG Neonatal TSH ELISA kit is specifically designed to quantitate human thyr

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 1

Galactose (with Membrane Plate) ELISA - 00840239014863 Catalog Number : EIA-1486

Device Description : The DRG Galactose kit is designed for the quantitative determination of galactos

Device Class : 1

Duns Number: 075150847

Premarket Exempt : No

Product Code : JIA

Prescription Use : Yes

Device Count : 1

Galactose (without Membrane Plate) ELISA - 00840239014870 Catalog Number : EIA-1487

Device Description : The DRG Galactose kit is designed for the quantitative determination of galactos

Device Class : 1

Duns Number: 075150847

Premarket Exempt : No

Product Code : JIA

Prescription Use : Yes

Device Count : 1

Galactose (with Membrane Plate) ELISA - 00840239014887 Catalog Number : EIA-1488

Device Description : The DRG neonatal Galactose ELISA is designed for the quantitative determination

Device Class : 1

Duns Number: 075150847

Premarket Exempt : No

Product Code : JIA

Prescription Use : Yes

Device Count : 1

Galactose (without Membrane Plate) ELISA - 00840239014894 Catalog Number : EIA-1489

Device Description : The DRG neonatal Galactose ELISA is designed for the quantitative determination

Device Class : 1

Duns Number: 075150847

Premarket Exempt : No

Product Code : JIA

Prescription Use : Yes

Device Count : 1

Triiodothyronine (T3) ELISA - 00840239017802 Catalog Number : EIA-1780

Device Description : This Triiodothyronine (T3) ELISA is intended for the quantitative determination

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : CDP

Prescription Use : Yes

Device Count : 1

Total Thyroxine (T4) ELISA - 00840239017819 Catalog Number : EIA-1781

Device Description : For the quantitative determination of total thyroxine (T4) concentration in huma

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : KLI

Prescription Use : No

Device Count : 1

Thyroid Stimulating Hormone (TSH) ELISA - 00840239017826 Catalog Number : EIA-1782

Device Description : For the quantitative determination of thyroid stimulating hormone (TSH) concentr

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JLW

Prescription Use : No

Device Count : 1

Human Chorionic Gonadotropin (hCG) ELISA - 00840239017833 Catalog Number : EIA-1783

Device Description : The hCG ELISA is intended for the quantitative determination of human chorionic

Device Class : 2

Duns Number: 075150847

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

Follicle Stimulating Hormone (FSH) ELISA - 00840239017857 Catalog Number : EIA-1785

Device Description : The FSH ELISA is intended for the quantitative determination of FSH concentratio

Device Class : 1

Duns Number: 075150847

Premarket Exempt : Yes

Product Code : NGA

Prescription Use : Yes

Device Count : 1

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