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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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3-LD Set, PINCH to TWIN, A, 29, TEL COM - 00840828148764

3-LD Set, PINCH to TWIN, A, 29, TEL COM
CURBELL MEDICAL PRODUCTS, INC.
LW-3300029/3AT
In Commercial Distribution

  • 00840828148764 ()
9233

  • Electrocardiographic lead set, reusable

JBAIDS - 00851458005068

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)

cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System - 00875197005608

No Description
Roche Molecular Systems, Inc.
07341890190
In Commercial Distribution

  • 00875197005608 ()
07341890190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System - 00875197005950

No Description
Roche Molecular Systems, Inc.
08160104190
In Commercial Distribution

  • 00875197005950 ()
08160104190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System - 00875197005653

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

  • 00875197005653 ()
07402686190

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Alere™ i Influenza A & B - 10811877010804

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)

ID NOW Influenza A & B 2 - 10811877010422

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)

Alere i Influenza A & B 2 - 10811877010019

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)

LIAISON XL MUREX HBsAg Confirmatory - 08056771103589

No Description
DIASORIN S.P.A.
318110
In Commercial Distribution

  • 28056771103583 ()
  • 08056771103589 ()


  • Hepatitis B virus surface antigen IVD, reagent

LIAISON XL MUREX HBcIgM - 08056771103381

No Description
DIASORIN SPA
318140
In Commercial Distribution

  • 08056771103381 ()
  • 18056771103388 ()


  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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