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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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No Description
Roche Molecular Systems, Inc.
07402686190
In Commercial Distribution

  • 00875197005653 ()
07402686190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
07341890190
In Commercial Distribution

  • 00875197005608 ()
07341890190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
JBAIDS IVD Influenza A & B Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0137
Not in Commercial Distribution

  • 00851458005068 ()
JRPD-ASY-0137

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A rapid, automated, molecular test for the qualitative detection of inuenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
425-024
Not in Commercial Distribution

  • 10811877010804 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
In Commercial Distribution

  • 10811877010422 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
Not in Commercial Distribution

  • 10811877010019 ()


  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN S.P.A.
318110
In Commercial Distribution

  • 28056771103583 ()
  • 08056771103589 ()


  • Hepatitis B virus surface antigen IVD, reagent
No Description
DIASORIN SPA
318140
In Commercial Distribution

  • 08056771103381 ()
  • 18056771103388 ()


  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
P001928
In Commercial Distribution

  • 08056771102339 ()


  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
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