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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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Status AccuStrep A card; 25 Test kit
PRINCETON BIOMEDITECH CORPORATION
BSP-181-25-01
In Commercial Distribution

  • 10743816000792 ()
BSP-181-25-01

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Status Strep A card; Flip cassette; 25 Test kit
PRINCETON BIOMEDITECH CORPORATION
BSP-182-25-00
In Commercial Distribution

  • 10743816000785 ()
BSP-182-25-00

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
DIASORIN MOLECULAR LLC
IF0010
Not in Commercial Distribution

  • 10816101020017 ()


  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
Alere Signify™ Strep A Dipstick
ALERE SAN DIEGO, INC.
01P46-50
In Commercial Distribution

  • 10815845020055 ()
  • 00815845020058 ()
4584925047

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Alere Acceava™ Strep A
ALERE SAN DIEGO, INC.
92001
In Commercial Distribution

  • 10815845020031 ()
  • 00815845020034 ()
4580295008

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Clearview™ Strep A Exact II Dipstick
ALERE SAN DIEGO, INC.
92002
In Commercial Distribution

  • 10815845020024 ()
  • 00815845020027 ()
4581225020

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
Roche Diagnostics GmbH
4340892190
In Commercial Distribution

  • 04015630997459 ()
4340892190

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2861-2010 A
Not in Commercial Distribution

  • 04049016081715 ()


  • Candida albicans immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-2010 A
Not in Commercial Distribution

  • 04049016078449 ()


  • Mycoplasma pneumoniae immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2202-2005 A
Not in Commercial Distribution

  • 04049016055136 ()


  • Mycoplasma pneumoniae immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassay
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