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Device Description : The Stanbio STAT-Site® MHgb Test Kit is intended for the quantitative determinat The Stanbio STAT-Site® MHgb Test Kit is intended for the quantitative determination of hemoglobin in whole blood using the Stanbio STAT-Site® MHgb Meter. The STAT-Site® MHgb Test may be used with adults, infants, and children in a physician’s office or other professional point-of-care setting.
Device Class :
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : A bi-level reference control intended for use on STAT-Site® and HemoSite® hemogl A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System.
Device Class : 2
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to acc The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to accept only STAT-Site® M Hgb CODE Keys and STAT-Site® M Hgb Test Cards. This test system is intended for the quantitative determination of hemoglobin in the whole blood of adults, infants, and children in a physician’s office or other professional point-of-care setting.
Device Class : 2
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : The HemoPoint® H2 system is intended for the quantitative determination of hemog The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents.
Device Class : 2
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.
Device Class :
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin t A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : This instrument is intended to be used to read and calculate the results of in-v This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : This instrument is intended to be used to read and calculate the results of in-v This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application.
Device Class : 1
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : For the In Vitro Quantitative Determination of Acetaminophen in Serum.
Device Class : 2
Duns Number: 045361136
Premarket Exempt : No
Prescription Use : Yes
Device Description : For the Quantitative Colorimetric Determination of Albumin in Serum or Plasma.
Device Class : 2
Duns Number: 045361136
Premarket Exempt : Yes
Prescription Use : Yes