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Device Description : Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen on red blood cells by tube test.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This monoclonal reagent is used for the detection of the Fya antigen (of the Duf This monoclonal reagent is used for the detection of the Fya antigen (of the Duffy 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 : Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the det Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is intended for the detection of the Fya (FY1) antigen on red blood cells with the indirect antiglobulin test by tube and microplate technique.Gamma-clone Anti-Fya (Monoclonal) Blood Grouping Reagent is prepared from IgG antibodies from the human/murine heterohybridoma cell line P3TIM grown in fluid culture and suitably diluted in a proprietary diluent containing bovine albumin to achieve the appropriate level of potency for the test procedure as described. Sodium azide is added as a preservative (at less than 0.1% w/v). Ready for use as supplied.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : No
Device Description : Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma.
Device Class : 1
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : No
Device Description : Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R 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.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : No
Device Description : Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Captur Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the detection of IgG antibodies to platelets. Capture-P Indicator Red Cells are a suspension of red blood cells coated with rabbit anti-human IgG. The red blood cells are suspended in a buffered preservative solution to which chloramphenicol (0.25 mg/mL) , neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) have been added as preservatives.
Device Class : 1
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : No
Device Description : The NEO Iris is a microprocessor-controlled instrument to fully automate immunoh The NEO Iris is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO Iris automates test processing, result interpretation and data management functions. The NEO Iris is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping and antigen screening. The NEO Iris is for in-vitro diagnostic use.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Echo Lumena is a microprocessor-controlled instrument designed to fully auto The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping.
Device Class : 2
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. 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. The antigens Mia and Mur are represented with this product version.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Anti-Cw (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the dete Anti-Cw (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Cw (RH8) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes