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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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QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High Altitude - 14053228002137

No Description
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002137 ()
  • 04053228002130 ()
5970405

  • Interferon gamma release IVD, reagent

QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - 14053228002120

QF-TB Gold Blood collection tubes - Dispenser Pack (25 single patient packs)
QIAGEN SCIENCES INC.
1
In Commercial Distribution

  • 14053228002120 ()
  • 04053228002123 ()
5970403

  • Interferon gamma release IVD, reagent

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

OSOM Flu Dipstick 25 Test Kit - 00742860001901

No Description
SEKISUI DIAGNOSTICS, LLC
190
Not in Commercial Distribution

  • 00742860001901 ()
  • 10742860001908 ()
190

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

OSOM ULTRA PLUS FLU A&B Test - 00742860100390

No Description
SEKISUI DIAGNOSTICS, LLC
1032
In Commercial Distribution

  • 10742860100397 ()
  • 00742860100390 ()


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

Acucy Flu Test Kit - 00742860100376

Acucy Influenza A&B Test Kit
SEKISUI DIAGNOSTICS, LLC
1010
In Commercial Distribution

  • 00742860100376 ()
  • 10742860100373 ()


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

OSOM Ultra Flu A&B 25T Kit - 00742860100222

OSOM Ultra Flu A&B 25T Kit
SEKISUI DIAGNOSTICS, LLC
1006
In Commercial Distribution

  • 00742860100222 ()
  • 10742860100229 ()
1006

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

Henry Schein - 00304040019771

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

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
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