Device Description : Gold Kit 80-100 Test
Device Class : 2
Duns Number: 144968104
Premarket Exempt : Yes
Prescription Use : No
Device Description : DS5 HbA1c Control (2-level) (3x 0.5mL L1, 3x 0.5mL L2)
Device Class : 2
Duns Number: 144968104
Premarket Exempt : No
Prescription Use : No
Device Description : DS5 HbA1c Control (2-level) (2 x 3 x 0.5mL)
Device Class : 2
Duns Number: 144968104
Premarket Exempt : No
Prescription Use : No
Device Description : DS360 - HbA1c Control (3x 0.5mL L1, 3x 0.5mL L2, 1x 4mL Diluent, 1x 100mL Hemolyzer)
Device Class : 2
Duns Number: 144968104
Premarket Exempt : No
Prescription Use : No
Device Description : DS5 Pink Kit (300 test)
Device Class : 2
Duns Number: 144968104
Premarket Exempt : No
Prescription Use : No
Device Description : Pink Kit Hemolyzer (440mL)
Device Class : 1
Duns Number: 144968104
Premarket Exempt : Yes
Prescription Use : No
Device Description : DS5 HbA1c Calibrator (4x 0.5mL L1, 4x 0.5mL L2, 1x 6mL Diluent)
Device Class : 2
Duns Number: 144968104
Premarket Exempt : No
Prescription Use : No
Device Description : DS5 HbA1c Calibrator (1 and 2) (2 x 4 x 0.5mL)
Device Class : 2
Duns Number: 144968104
Premarket Exempt : No
Prescription Use : No
Device Description : DS360 HbA1c Calibrator (2x 0.5 mL L1, 2x 0.5mL L2, 1x 4mL Dil, 1x 25mL Hemolyzer)
Device Class : 2
Duns Number: 144968104
Premarket Exempt : No
Prescription Use : No
Device Description : DS360 Reagent Test Kit (500 tests)
Device Class : 2
Duns Number: 144968104
Premarket Exempt : Yes
Prescription Use : No