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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; 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
QkVue Flu A+B 20K-T, Bulk
QUIDEL CORPORATION
20189
In Commercial Distribution

  • 30014613331469 ()
20189

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Sofia Flu A+B 25T
QUIDEL CORPORATION
20254
In Commercial Distribution

  • 30014613202547 ()
20254

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Sofia Flu A+B 25T
QUIDEL CORPORATION
20218
In Commercial Distribution

  • 30014613202189 ()
20218

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
QkVue Flu A+B 25T, CE
QUIDEL CORPORATION
20183
In Commercial Distribution

  • 30014613201830 ()
20183

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
QkVue Flu Bulk 25T
QUIDEL CORPORATION
00317
In Commercial Distribution

  • 30014613003175 ()
00317

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
The COVID-19/Flu A&B Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of COVID-19, Influenza A&B Antigen in Nasal swab. It is intended to aid in the rapid differential diagnosis of COVID-19,Influenza A and B
Zhengzhou Shiyi Biotech Co., Ltd.
A003
In Commercial Distribution

  • 26977977230038 ()
  • 16977977230031 ()
  • 06977977230034 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
The COVID-19/Flu A&B Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of COVID-19, Influenza A&B Antigen in Nasal swab. It is intended to aid in the rapid differential diagnosis of COVID-19,Influenza A and B
Zhengzhou Shiyi Biotech Co., Ltd.
A002
In Commercial Distribution

  • 26977977230021 ()
  • 16977977230024 ()
  • 06977977230027 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
No Description
SEKISUI DIAGNOSTICS, LLC
190
Not in Commercial Distribution

  • 00742860001901 ()
  • 10742860001908 ()
190

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Slim Body Skin Stapler
Covidien LP
8886803512
In Commercial Distribution

  • 30884521104369 ()
  • 10884521104365 ()
  • 20884521104362 ()

  • Regular,N/A,N/A;


  • Skin stapler/staple, non-bioabsorbable
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