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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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BioSign Flu A+B; 10 Test Kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-510-10-00
In Commercial Distribution

  • 10743816001201 ()
BSP-510-10-00

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Status Flu A+B; 22 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-22-01
In Commercial Distribution

  • 10743816001195 ()
BSP-510-22-01

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
BioSign Flu A+B; 22 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-22-00
In Commercial Distribution

  • 10743816001188 ()
BSP-510-22-00

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Status Flu A+B; 25 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-25-02
In Commercial Distribution

  • 10743816001508 ()
BSP-510-25-02

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Status Flu A+B; 5 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-05-00
In Commercial Distribution

  • 10743816001447 ()
BSP-510-05-00

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Status Flu A+B Nasopharyngeal Wash/Aspirate Kit; 44 Pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-04
In Commercial Distribution

  • 10743816001416 ()
BSP-510AS-04

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
Status Flu A & B; 4 Test Sample Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-04-00
In Commercial Distribution

  • 10743816001218 ()
BSP-510-04-00

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Rapid test for the quantitative detection of Influenza A&B antigens in nasal swab specimens
HENRY SCHEIN, INC.
1126219
In Commercial Distribution

  • 10304040019778 ()
  • 00304040019771 ()
1126219

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Xpect Flu A&B Control 20Swab/SET
REMEL, INC.
R246003
In Commercial Distribution

  • 30848838063702 ()
  • 00848838063701 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
No Description
Orasure Technologies, Inc.
1001-0321
In Commercial Distribution

  • 00608337000047 ()


  • Influenza A/B virus antigen IVD, reagent
  • Nasopharyngeal aspirate container IVD
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