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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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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
Phonak Slim L50-R Left (cooper/black)
Sonova AG
050-1009-4A
In Commercial Distribution

  • 07613389480443 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
Moxi B3-RS Right (sand)
Sonova AG
050-6473-R8
In Commercial Distribution

  • 07613389528084 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
Moxi B5-RS Left (platinum)
Sonova AG
050-6474-P6
In Commercial Distribution

  • 07613389527353 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
No Description
Response Biomedical Corp
C1135
Not in Commercial Distribution

  • 10627966005190 ()


  • Influenza A/B virus antigen IVD, control
Control swabs intended for use only with Strep A product.
Alere Scarborough, Inc.
730-010
In Commercial Distribution

  • 10811877010446 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, control
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
Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.
Alere Scarborough, Inc.
575-080
In Commercial Distribution

  • 10811877010989 ()


  • Influenza A/B virus antigen IVD, control
The Control Swabs are intended for use only with the Alere Influenza A & B Test.
Alere Scarborough, Inc.
412-080
Not in Commercial Distribution

  • 10811877010880 ()


  • Influenza A/B virus antigen IVD, control
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