Address:3130 GATEWAY DR.,Norcross,GA,30071,US
Device Description : This configuration of the product contains two (2) vials, and is used for the co This configuration of the product contains two (2) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Panoscreen I, II, and III is intended for use in the detection of unexpected IgG Panoscreen I, II, and III is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of this product is a 3-cell screen.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Panoscreen I and II is intended for use in the detection of unexpected IgG antib Panoscreen I and II is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of this product is a 2-cell screen.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Panoscreen I, II, and III is intended for use in the detection of unexpected IgG Panoscreen I, II, and III is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of this product is a 3-cell screen.
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. Panocell-10, Ficin-Treated is a 12-vial set of 10 vials of red blood cells, plus one vial each of Ficin Solution and Ficin Control.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is used in the detection of unexpected red blood cell blood group a This product is used in the detection of unexpected red blood cell blood group antibodies. This product is a two (2) vial set, with each vial containing a 2 - 4% reagent red blood cell suspension of a unique group O donor of known antigen make-up.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : corQC Test System is used for daily quality control evaluation of routine blood corQC Test System is used for daily quality control evaluation of routine blood bank reagents. It is a two vial set. One vial is a suspension of known red blood cells. The second vial is a known antiserum containing antibodies.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated a corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a three vial set.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Weak D Cells are used for quality control of weak D testing. Weak D Cells are a Weak D Cells are used for quality control of weak D testing. Weak D Cells are a suspension of selected weak D red blood cells. This product is a one (1) vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : Yes
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 10 vials of reagent red blood cells in a set, as well as one (1) Tech Cell and also one (1) buffered preservation diluent. 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