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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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N/A
GALEMED CORPORATION
5427
In Commercial Distribution

  • 44710810089860 ()
  • 04710810089862 ()
CPAP Full Face Mask Medium w/Harness

  • CPAP/BPAP face mask, single-use
N/A
Conformis, Inc.
RCR010090001
In Commercial Distribution

  • M572RCR0100900011 ()

  • Length: 9 Millimeter
RCR0100900

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
No Description
THE BINDING SITE GROUP LIMITED
NK012.10S
In Commercial Distribution

  • 05051700016698 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK012.S
Not in Commercial Distribution

  • 05051700012249 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Combo Veritor Plus CLIA- Waived Flu Kit
BECTON, DICKINSON AND COMPANY
256074
In Commercial Distribution

  • 00382902560746 ()
256074

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
BD Veritor™ System Laboratory Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, Laboratory Kits (Cat. No. 256041) 1xBD Veritor ™ Plus Analyzer (Cat. No. 256066)
BECTON, DICKINSON AND COMPANY
256073
In Commercial Distribution

  • 00382902560739 ()
256073

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis.
LUMINEX CORPORATION
50-10041
Not in Commercial Distribution

  • 00840487101469 ()


  • Beta-haemolytic Group A Streptococcus 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)
B. burgdorferi WB IgG Serum Band Locator, 250µL
MARDX DIAGNOSTICS, INC.
40-2023L
In Commercial Distribution

  • 05391516747622 ()
40-2023L

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Legionella IFA Test System,(Legionella species), 180 Tests
MARDX DIAGNOSTICS, INC.
30-7980
In Commercial Distribution

  • 05391516747820 ()
30-7980

  • Legionella longbeachae immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
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