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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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BD Veritor™ Plus Laboratory Combo Pack - 00382902560708

Combo Veritor Reader 2 Hospital Flu Kit
BECTON, DICKINSON AND COMPANY
256070
Not in Commercial Distribution

  • 00382902560708 ()
256070

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

BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waved kit - 00382902560456

Kit Flu A+B 30 Test Physician Veritor
BECTON, DICKINSON AND COMPANY
256045
In Commercial Distribution

  • 00382902560456 ()
256045

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

BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit - 00382902560418

Kit Flu A+B 30 Test Hospital Veritor
BECTON, DICKINSON AND COMPANY
256041
In Commercial Distribution

  • 00382902560418 ()
256041

  • 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

Horizon - 00382906666611

BD Horizon™ Anti-Human IgM (G20-127) BV605
Becton, Dickinson And Company
666661
In Commercial Distribution

  • 00382906666611 ()
666661

  • Interferon gamma release IVD, reagent

N/A - 00382906666451

BD® Anti-Human IgD (IA6-2) PerCP-Cy5.5
Becton, Dickinson And Company
666645
In Commercial Distribution

  • 00382906666451 ()
666645

  • Interferon gamma release IVD, reagent

N/A - 00382906559333

IFN GAMMA APC (25723.11) ASR
Becton, Dickinson And Company
655933
In Commercial Distribution

  • 00382906559333 ()
655933

  • Interferon gamma release IVD, reagent

Remel - 00848838027031

Xpect Flu A&B KT/20TST
REMEL, INC.
R24600
In Commercial Distribution

  • 30848838027032 ()
  • 00848838027031 ()


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

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

SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +) - 05055273216523

Serology III Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Hepatitis B Core Antigen (HBc IgM) and IgM antibodies to Hepatitis A (HAV IgM). Serology III Positive Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology III Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10354
In Commercial Distribution

  • 05055273216523 ()
SR10354

  • Multiple-type blood-borne pathogen antibody/antigen IVD, control
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