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Device Description : The Echinococcus IgG Enzyme Immunoassay Kit provides materials for the qualitati The Echinococcus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Echinococcus in human serum and plasma. This assay is intended for in vitro diagnostic use only.
Device Class : 1
Duns Number: 784143778
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Estradiol Ultrasensitive ELISA is an enzyme immunoassay for the quantitative The Estradiol Ultrasensitive ELISA is an enzyme immunoassay for the quantitative measurement of Estradiol in serum and plasma. For In Vitro Diagnostic Use.
Device Class : 1
Duns Number: 784143778
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro di The Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol (unconjugated estriol) in serum during the second half of pregnancy.
Device Class : 1
Duns Number: 784143778
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The LH (Urine) ELISA is an enzyme immunoassay for the quantitative in vitro diag The LH (Urine) ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of LH in urine. For in vitro diagnostic use.
Device Class : 1
Duns Number: 784143778
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The TGF Beta-1 ELISA is an enzyme immunoassay for the quantitative in vitro diag The TGF Beta-1 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of TGF Beta-1 in serum and cell culture supernatant. For in vitro diagnostic use.
Device Class : 1
Duns Number: 784143778
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Adrenocorticotropic Hormone ELISA is intended for use in the quantitative de The Adrenocorticotropic Hormone ELISA is intended for use in the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human EDTA plasma.
Device Class : 2
Duns Number: 784143778
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Calcitonin ELISA is intended for use in the quantitative determination of Ca The Calcitonin ELISA is intended for use in the quantitative determination of Calcitonin in human serum.
Device Class : 2
Duns Number: 784143778
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EPO ELISA is intended for use in the quantitative determination of Erythropo The EPO ELISA is intended for use in the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias.
Device Class : 2
Duns Number: 784143778
Premarket Exempt : No
Prescription Use : Yes
Device Description : The PTH (Intact, 1-84) ELISA is intended for use in the quantitative determinati The PTH (Intact, 1-84) ELISA is intended for use in the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum.
Device Class : 2
Duns Number: 784143778
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin competes with albumin insamples for limited antibody binding sites on the microplate. After incubation for a fixed time, separation of bound fromfree is achieved by simple decantation and plate washing. The enzyme activity on the plate is measured using an enzymesubstrate and a chromogen. The absorbency of the color developed is read in an ELISA colorimetric reader. The measuredabsorbance is inversely proportional to the concentration of bound albumin in the microplate. The concentration ofalbumin in the urine is determined from a calibration curve.
Device Class : 2
Duns Number: 784143778
Premarket Exempt : Yes
Prescription Use : Yes