Address:841 Mountain Ave,Springfield,NJ,07081,US
Device Description : The DRG Neonatal TSH ELISA kit is specifically designed to quantitate human thyr The DRG Neonatal TSH ELISA kit is specifically designed to quantitate human thyroid stimulating hormone from neonatal blood spot samples collected on Schleicher and Schuell’s filter paper #903.
Device Class : 2
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DRG Galactose kit is designed for the quantitative determination of galactos The DRG Galactose kit is designed for the quantitative determination of galactose in neonatal blood spots. It is for in-vitro diagnostic use as an aid in screening newborns for the elevated galactose levels as seen in galactosemia.
Device Class : 1
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DRG Galactose kit is designed for the quantitative determination of galactos The DRG Galactose kit is designed for the quantitative determination of galactose in neonatal blood spots. It is for in-vitro diagnostic use as an aid in screening newborns for the elevated galactose levels as seen in galactosemia.
Device Class : 1
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DRG neonatal Galactose ELISA is designed for the quantitative determination The DRG neonatal Galactose ELISA is designed for the quantitative determination of galactose in neonatal blood spots. It is for in vitro diagnostic use as an aid in screening newborns for elevated galactose levels as seen in galactosemia.
Device Class : 1
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DRG neonatal Galactose ELISA is designed for the quantitative determination The DRG neonatal Galactose ELISA is designed for the quantitative determination of galactose in neonatal blood spots. It is for in vitro diagnostic use as an aid in screening newborns for elevated galactose levels as seen in galactosemia.
Device Class : 1
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : Yes
Device Description : This Triiodothyronine (T3) ELISA is intended for the quantitative determination This Triiodothyronine (T3) ELISA is intended for the quantitative determination of triiodothyronine (T3) concentration inhuman serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
Device Class : 2
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : Yes
Device Description : For the quantitative determination of total thyroxine (T4) concentration in huma For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Device Class : 2
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of thyroid stimulating hormone (TSH) concentr For the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.
Device Class : 2
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : No
Device Description : The hCG ELISA is intended for the quantitative determination of human chorionic The hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting.
Device Class : 2
Duns Number: 075150847
Premarket Exempt : No
Prescription Use : No
Device Description : The FSH ELISA is intended for the quantitative determination of FSH concentratio The FSH ELISA is intended for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders.
Device Class : 1
Duns Number: 075150847
Premarket Exempt : Yes
Prescription Use : Yes