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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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The Anti-Lea reagent (Anti-LE1) is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904557
In Commercial Distribution

  • 10758750013104 ()


  • Anti-Le^a red blood cell grouping IVD, antibody
The Anti-Jka reagent (Anti-JK1) is for the qualitative in vitro detection of human Jka positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904548
In Commercial Distribution

  • 10758750013029 ()


  • Anti-Jk^a red blood cell grouping IVD, antibody
The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect antiglobulin test.
ALBA BIOSCIENCE LIMITED
6904546
In Commercial Distribution

  • 10758750013005 ()


  • Anti-Fy^a red blood cell grouping IVD, antibody
Anti-Jka (Monoclonal) BioClone
ORTHO-CLINICAL DIAGNOSTICS, INC.
721380
In Commercial Distribution

  • 10758750004140 ()
721380

  • Anti-Jk^a red blood cell grouping IVD, antibody
ANTI-LEA (LE1) (MURINE MONOCLONAL) BIOCLONE 2.0
ORTHO-CLINICAL DIAGNOSTICS, INC.
715280
In Commercial Distribution

  • 10758750003389 ()
715280

  • Anti-Le^a red blood cell grouping IVD, antibody
ANTI-FYA (ANTI-DUFFY A) 1X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
715130
In Commercial Distribution

  • 10758750003365 ()
715130

  • Anti-Fy^a red blood cell grouping IVD, antibody
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3923
Not in Commercial Distribution

  • 00840487100219 ()
3923

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Control Swabs intended for use only with the ID NOW Influenza A & B 2 product.
Alere Scarborough, Inc.
425-080
In Commercial Distribution

  • 10811877011221 ()


  • Influenza A/B virus nucleic acid IVD, control
Control Swabs intended for use only with the Alere i Strep A product.
Alere Scarborough, Inc.
733-080
Not in Commercial Distribution

  • 10811877010866 ()


  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
Control Swabs intended for use only with the Alere i Inuenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010811 ()


  • Influenza A/B virus nucleic acid IVD, control
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