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Device Description : This product is intended for use in slide, tube, and microplate tests, for the d This product is intended for use in slide, tube, and microplate tests, for the detection of both the A and B antigens.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Anti-D Series 4 (Monoclonal Blend) is intended for use in slide, tube, microplat Anti-D Series 4 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplat Anti-D Series 5 (Monoclonal Blend) is intended for use in slide, tube, microplate and automated tests, for the detection of the Rh (D) antigen.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Capture LISS is for use as a low ionic strength potentiator and sample addition Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 11.5 mL vial version with one vial packaged.
Device Class : 1
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Capture LISS is for use as a low ionic strength potentiator and sample addition Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 11.5 mL vial version with ten vials packaged.
Device Class : 1
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-S This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the single vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-S This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the ten (10) vial configuration.
Device Class : 2
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.
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. 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
Device Description : Capture-R Select solid phase system provides modified micro-wells for the immobi Capture-R Select solid phase system provides modified micro-wells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping). This product is the five (5) plate configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes