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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-61401
Not in Commercial Distribution

  • 10856626006066 ()
  • 00856626006069 ()
991-61401

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
990-28011
Not in Commercial Distribution

  • 10856626006035 ()
  • 00856626006038 ()
990-28011

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
464-01601
Not in Commercial Distribution

  • 10856626006028 ()
  • 00856626006021 ()
464-01601

  • Triglyceride IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
276-76491
Not in Commercial Distribution

  • 10856626006011 ()
  • 00856626006014 ()
276-76491

  • Non-esterified fatty acid IVD, calibrator
A ZOICX Additive Sterile Filtered
Incell Corporation, LLC
ZDAN04
In Commercial Distribution

  • G507ZDAN040 ()
ZDAN04

  • Cell culture medium IVD
No Description
SEPTODONT, INC
01C2080
In Commercial Distribution

  • 00303620000857 ()

  • Weight: 4.5 Gram


  • Dental etching solution
  • Dental composite resin
  • Dentine adhesive
No Description
SEPTODONT, INC
01C2030
In Commercial Distribution

  • 00303620000611 ()

  • Total Volume: 5 Milliliter
01C2030

  • Dentine adhesive
Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test.
IMMUCOR, INC.
0066428
In Commercial Distribution

  • 10888234002437 ()
0066428

  • Anti-S [MNS003] red blood cell grouping IVD, antibody
Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen on red blood cells by tube test.
IMMUCOR, INC.
0066429
In Commercial Distribution

  • 10888234002420 ()
0066429

  • Anti-S [MNS004] red blood cell grouping IVD, antibody
Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent is intended for the detection of the k (KEL2) antigen on red blood cells by indirect agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004817
In Commercial Distribution

  • 10888234002390 ()
0004817

  • Anti-k (KEL002) red blood cell grouping IVD, antibody
Anti-Fyb (Monoclonal) Gamma-clone Blood Grouping Reagent is intended for the detection of the Fyb (FY2) antigen on red blood cells by direct agglutination tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004818
In Commercial Distribution

  • 10888234002383 ()
0004818

  • Anti-Fy^b red blood cell grouping IVD, antibody
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.
IMMUCOR, INC.
0004819
In Commercial Distribution

  • 10888234002376 ()
0004819

  • Anti-C^w red blood cell grouping IVD, antibody
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.
IMMUCOR, INC.
0004816
In Commercial Distribution

  • 10888234002222 ()
0004816

  • Anti-Fy^a red blood cell grouping IVD, antibody
Anti-s (Monoclonal) Gamma-clone reagent is intended for the detection of the s (MNS4) antigen on red blood cells by tube test.
IMMUCOR, INC.
0004815
In Commercial Distribution

  • 10888234002215 ()
0004815

  • Anti-S [MNS004] red blood cell grouping IVD, antibody
Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test.
IMMUCOR, INC.
0004814
In Commercial Distribution

  • 10888234002208 ()
0004814

  • Anti-S [MNS003] red blood cell grouping IVD, antibody
This monoclonal reagent is used for the detection of the Jkb antigen (of the Kidd blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004813
In Commercial Distribution

  • 10888234002192 ()
0004813

  • Anti-Jk^b red blood cell grouping IVD, antibody
This reagent is used for the detection of the Jka antigen (of the Kidd blood group system) on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0004812
In Commercial Distribution

  • 10888234002185 ()
0004812

  • Anti-Jk^a red blood cell grouping IVD, antibody
Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has one (1) vial.
IMMUCOR, INC.
0066087
In Commercial Distribution

  • 10888234002178 ()
0066087

  • Multiple immunohaematology test IVD, control
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 single 57 mL bottle version.
IMMUCOR, INC.
0006418
In Commercial Distribution

  • 10888234002147 ()
0006418

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
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.
IMMUCOR, INC.
0006415
In Commercial Distribution

  • 10888234002017 ()
0006415

  • Anti-Rh(D) red blood cell grouping IVD, antibody
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.
IMMUCOR, INC.
0006413
In Commercial Distribution

  • 10888234002000 ()
0006413

  • Anti-Rh(D) red blood cell grouping IVD, antibody
Anti-B (Murine Monoclonal) Series 3 is intended for use in slide, tube, microplate and automated tests, for the detection of the B antigen.
IMMUCOR, INC.
0006407
In Commercial Distribution

  • 10888234001997 ()
0006407

  • Anti-B red blood cell grouping IVD, antibody
This reagent is used in slide, tube, microplate and automated tests, for the detection of the A antigen of the ABO blood group system. The package configuration for this product code is one (1) vial of reagent.
IMMUCOR, INC.
0006401
In Commercial Distribution

  • 10888234001980 ()
0006401

  • Anti-A red blood cell grouping IVD, antibody
This reagent is intended for the detection of the N antigen on red blood cells by tube test.
IMMUCOR, INC.
0004807
In Commercial Distribution

  • 10888234001904 ()
0004807

  • Anti-N red blood cell grouping IVD, antibody
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.
IMMUCOR, INC.
0004864
In Commercial Distribution

  • 10888234001898 ()
0004864

  • Anti-Le^b red blood cell grouping IVD, antibody
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.
IMMUCOR, INC.
0004861
In Commercial Distribution

  • 10888234001881 ()
0004861

  • Anti-Le^a red blood cell grouping IVD, antibody
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.
IMMUCOR, INC.
0005020
In Commercial Distribution

  • 10888234001843 ()
0005020

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
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.
IMMUCOR, INC.
0004140
In Commercial Distribution

  • 10888234001836 ()
0004140

  • Anti-K (KEL001) red blood cell grouping IVD, antibody
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.
IMMUCOR, INC.
0705410
In Commercial Distribution

  • 10888234001812 ()
0705410

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
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