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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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Control Swabs intended for use only with Alere BinaxNOW® Influenza A & B Card 2 product.
Alere Scarborough, Inc.
575-080
Not in Commercial Distribution

  • 10811877010194 ()


  • Influenza A/B virus antigen IVD, control
No Description
DIASORIN SPA
310201
In Commercial Distribution

  • 08056771100205 ()


  • Hepatitis A virus total antibody IVD, control
VITROS Immunodiagnostic Products Anti-HAV Total Controls
ORTHO CLINICAL DIAGNOSTICS
6801463
In Commercial Distribution

  • 10758750001293 ()
6801463

  • Hepatitis A virus total antibody IVD, control
No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control
George King Factor XIII Deficient plasma is fresh frozen human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-250.0
In Commercial Distribution

  • 00815696021150 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient Plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-100.0
In Commercial Distribution

  • 00815696020986 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient Plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-bulk
In Commercial Distribution

  • 00815696020955 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-50
In Commercial Distribution

  • 00815696020344 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-1.0
In Commercial Distribution

  • 00815696020337 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-0.5
In Commercial Distribution

  • 00815696020320 ()


  • Coagulation factor XIII A subunit IVD, control
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