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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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Blood Grouping Reagent Anti-Fya (FY1); Seraclone® Human Monoclonal (DG-FYA-02); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808188100
In Commercial Distribution

  • 07611969951833 ()
808188100

  • Anti-Fy^a red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-Jka (JK1); Seraclone® Human Monoclonal (MS15); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808179100
In Commercial Distribution

  • 07611969951758 ()
808179100

  • Anti-Jk^a red blood cell grouping IVD, antibody
No Description
Roche Diagnostics GmbH
20766399122
In Commercial Distribution

  • 04015630915644 ()
20766399122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
No Description
Roche Diagnostics GmbH
20766305122
In Commercial Distribution

  • 04015630915637 ()
20766305122

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
The illumigene Group A Streptococcus (Group A Strep) External Control Kit contains Positive Reagent for use with the illumigene Group A Streptococcus DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the Group A Strep Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279910
Not in Commercial Distribution

  • 00840733101328 ()
279910

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