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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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Control Swabs intended for use only with the ID NOW Influenza A & B 2 product.
Alere Scarborough, Inc.
425-080
In Commercial Distribution

  • 10811877011221 ()


  • Influenza A/B virus nucleic acid IVD, control
Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control
Control Swabs intended for use only with the Alere i Inuenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010811 ()


  • Influenza A/B virus nucleic acid IVD, control
Solana Flu A+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M122
In Commercial Distribution

  • 30014613336990 ()
M122

  • Influenza A/B virus nucleic acid IVD, control
L-DFA Influenza A/Influenza B Reagent
DIAGNOSTIC HYBRIDS, INC.
01-123104
In Commercial Distribution

  • 30014613330851 ()
01-123104

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
De Ultra DFA Influenza A/Influenza B Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010004.V2
In Commercial Distribution

  • 30014613330325 ()
01-010004.V2

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
QMol FLUA+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M106
In Commercial Distribution

  • 30014613311065 ()
M106

  • Influenza A/B virus nucleic acid IVD, control
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
No Description
Roche Molecular Systems, Inc.
08160104190
In Commercial Distribution

  • 00875197005950 ()
08160104190

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

  • 28056771103583 ()
  • 08056771103589 ()


  • Hepatitis B virus surface antigen IVD, reagent
No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution

  • B110CBG33200 ()
CBG-3320

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