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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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Anti-Dia - 10888234000839

This reagent is used for the detection of the Di(a) antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007620
In Commercial Distribution

  • 10888234000839 ()
0007620

  • Anti-Di^a red blood cell grouping IVD, antibody

Anti-Jka - 10888234000815

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.
0007601
In Commercial Distribution

  • 10888234000815 ()
0007601

  • Anti-Jk^a red blood cell grouping IVD, antibody

Anti-Fya - 10888234000792

This reagent is used for the detection of the Fya antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007591
In Commercial Distribution

  • 10888234000792 ()
0007591

  • Anti-Fy^a red blood cell grouping IVD, antibody

Anti-Kpa - 10888234000778

This reagent is used for the detection of the Kpa antigen on red blood cells by tube test. This product configuration is a single vial.
IMMUCOR, INC.
0007540
In Commercial Distribution

  • 10888234000778 ()
0007540

  • Anti-Kp^a red blood cell grouping IVD, antibody

Anti-Lea (LE1) - 23661562105414

Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) (13643B9) - This reagent is designed to determine the presence of the blood group antigen Lea (LE1) on the surface of human red blood cells by manual tube method.
DIAGAST
210541
In Commercial Distribution

  • 23661562105414 ()
210541

  • Anti-Le^a red blood cell grouping IVD, antibody

Anti-Jka (JK1) - 23661562105346

Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal) (P3HT7) - This reagent is designed to determine the presence of the blood group antigen Jka (JK1) on the surface of human red blood cells by manual tube method.
DIAGAST
210534
In Commercial Distribution

  • 23661562105346 ()
210534

  • Anti-Jk^a red blood cell grouping IVD, antibody

Anti-Fya (FY1) - 23661562105315

Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal) (IgG) (DG-FYA-02) - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual tube method.
DIAGAST
210531
In Commercial Distribution

  • 23661562105315 ()
210531

  • Anti-Fy^a red blood cell grouping IVD, antibody

Solana - 30014613336990

Solana Flu A+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M122
In Commercial Distribution

  • 30014613336990 ()
M122

  • Influenza A/B virus nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041493

QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel
MICROBIOLOGICS INC.
8219
In Commercial Distribution

  • 70845357041493 ()
8219

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Simplexa™ Group A Strep Positive Control Pack - 20816101025576

No Description
DIASORIN MOLECULAR LLC
MOL2860
In Commercial Distribution

  • 20816101025576 ()
MOL2860

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
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