Device Description : Elevated HCG Control Vial Label - A, for In Vitro Diagnostic Use. HCG Control is Elevated HCG Control Vial Label - A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : HCG Control Set Level A, for In Vitro Diagnostic Use. HCG Control is an unassaye HCG Control Set Level A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : HCG Control Set Level B, for In Vitro Diagnostic Use. HCG Control is an unassaye HCG Control Set Level B, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : AutoHDL™, For the quantitative determination high-density lipoprotein cholestero AutoHDL™, For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BS-480 analyzer. For in vitro diagnostic use only. Size: 4 x 57 ml, 4 x 18 ml.
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : HDL600, for the quantitative determination high-density lipoprotein cholesterol HDL600, for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BS-200 analyzer. For in vitro diagnostic use only. Size: 3 x 51 ml, 2 x 20 ml
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : auto HDL/LDL Calibrator, For the calibration of autoHDL™ and autoLDL™ Cholestero auto HDL/LDL Calibrator, For the calibration of autoHDL™ and autoLDL™ Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only. Size: 3 x 40mL, 3 x 14mL
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : MedTest DX Control Level 2 is a lyophilized human based control serum for use in MedTest DX Control Level 2 is a lyophilized human based control serum for use in the quality control of diagnostic assays. Human-sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control of reproducibility. Constituent concentrations are available at 2 levels. Size: 10 x 5 ml
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : MedTest DX Control Level 1 is a lyophilized human based control serum for use in MedTest DX Control Level 1 is a lyophilized human based control serum for use in the quality control of diagnostic assays. Human-sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control of reproducibility. Constituent concentrations are available at 2 levels. Size: 10 x 5 ml
Device Class : 1
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes
Device Description : Homocysteine, The Liquid Stable 2-Part Homocysteine Reagent is intended for in v Homocysteine, The Liquid Stable 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma on the Mindray BS-480 analyzer. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Size: 2 x 60ml, 2 x 12ml
Device Class : 2
Duns Number: 070371210
Premarket Exempt : No
Prescription Use : Yes