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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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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
ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit
ABBOTT LABORATORIES
1L75-55
In Commercial Distribution

  • 00380740001322 ()
01L7555

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent
ARCHITECT Cyclosporine Calibrators
ABBOTT LABORATORIES
1L75-01
In Commercial Distribution

  • 00380740001308 ()
01L7501

  • 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
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
Control Swabs intended for use only with the ID NOW Strep A 2 product.
Alere Scarborough, Inc.
734-080
In Commercial Distribution

  • 10811877010583 ()


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

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control
Control Swabs intended for use only with the Alere i Strep A 2 product.
Alere Scarborough, Inc.
734-080
Not in Commercial Distribution

  • 10811877010200 ()


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