Address:3130 GATEWAY DR.,Norcross,GA,30071,US
Device Description : Gamma N-HANCE is used an additive to enhance reactivity in the detection of unex Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This polyclonal reagent is used for the detection of the K antigen (of the Kell This polyclonal reagent is used for the detection of the K antigen (of the Kell blood group system) on red blood cells by tube test. This product configuration is a single vial.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is used in the identification of unexpected red cell blood group an This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as twenty (20) vials of reagent in a set. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpe Capture-R Ready-Screen (I and II) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains alternating wells coated with red blood cell membranes from one of two group O donors. Each strip consists of eight (8) individual wells to perform four (2-cell) antibody screens.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This reagent is used for the detection of the Lea antigen (of the Lewis system) This reagent is used for the detection of the Lea antigen (of the Lewis system) on red blood cells by tube test. This product configuration is a single vial.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This reagent is used for the detection of the Leb antigen (of the Lewis system) This reagent is used for the detection of the Leb antigen (of the Lewis system) on red blood cells by tube test. This product configuration is a single vial.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This reagent is intended for the detection of the N antigen on red blood cells b This reagent is intended for the detection of the N antigen on red blood cells by tube test.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains three (3) test wells coated with red blood cell membranes from three (3) group O donors, as well as a positive control well, which all make up one (1) test of four (4) wells. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Capture-R Ready-Screen (Pooled Cells) is intended for use in the detection of un Capture-R Ready-Screen (Pooled Cells) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. Each well is coated with red blood cell membranes prepared from a pool suspension of equal proportions of red blood cells from two Group O donors. Each strip consists of eight (8) individual wells to perform eight (8) antibody screens.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG Capture-R Ready-Screen (Pooled Cells) is used in the detection of unexpected IgG antibodies to red blood cells (in blood donors) by manual, semi-automated or automated solid phase red blood cell adherence methods. Each test well is prepared from a pool of two (2) group O donors. Each microplate strip consists of eight (8) individual wells to perform eight (8) antibody screens. Each microplate is packaged into a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes