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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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Remel - 00848838063701

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

Rapid Response - 00722066003343

Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of Influenza A and B Virus Antigens in nasal specimens.
BTNX Inc
FLUab-19C15
In Commercial Distribution

  • 00722066003343 ()
  • 00722066004241 ()
FLUab-19C15

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Poly stat - 00855574005407

Flu A & B, Immunochromatographic
POLYMEDCO, INC.
FLU22
In Commercial Distribution

  • 00855574005407 ()


  • Influenza A/B virus neuraminidase activity IVD, kit, rapid ICT, clinical

CHORUS INFLUENZA B IgG - 08033891327538

No Description
DIESSE DIAGNOSTICA SENESE SPA
81193
In Commercial Distribution

  • 08033891327538 ()
81193

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS INFLUENZA A IgG - 08033891327514

No Description
DIESSE DIAGNOSTICA SENESE SPA
81190
In Commercial Distribution

  • 08033891327514 ()
81190

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Status Flu A+B card - 10743816001508

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

BioSign Flu A+B card - 10743816001478

BioSign Flu A+B; 25 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-510-25-01
In Commercial Distribution

  • 10743816001478 ()
BSP-510-25-01

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Status Flu A & B - 10743816001447

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 Validation Kit - 10743816001430

Status Flu A+B Validation Kit; 22 Tests, 10 Positive Swabs, 10 Negative Swabs, 2 Regular Swabs
PRINCETON BIOMEDITECH CORPORATION
BSP-510-22-08
In Commercial Distribution

  • 10743816001430 ()
BSP-510-22-08

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Status Flu A+B Nasal Wash/Aspirate Kit - 10743816001416

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
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