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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.
08085471001
In Commercial Distribution

  • 07613336129692 ()
08085471001

  • Laboratory instrument/analyser application software IVD
AmpliVue GAS Assay
QUIDEL CORPORATION
Group A Strep Assay
Not in Commercial Distribution

  • 30014613312123 ()
M212

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2860
In Commercial Distribution

  • 20816101025576 ()
MOL2860

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
No Description
DIASORIN MOLECULAR LLC
MOL2850
In Commercial Distribution

  • 20816101025569 ()
MOL2850

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress Strep A kit; 10 test kit
CEPHEID
XPRSTREPA-10
In Commercial Distribution

  • 07332940006372 ()
XPRSTREPA-10

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress Strep A kit; 120 test kit
CEPHEID
XPRSTREPA-120
In Commercial Distribution

  • 07332940002503 ()
XPRSTREPA-120

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana Strep A/C & G Assay
DIAGNOSTIC HYBRIDS, INC.
M305
In Commercial Distribution

  • 30014613336136 ()
M305

  • Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana GAS Assay
QUIDEL CORPORATION
Group A Strep Assay
In Commercial Distribution

  • 30014613336082 ()
M301

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra Direct Strep Assay
QUIDEL CORPORATION
Direct Strep Assay
In Commercial Distribution

  • 30014613311126 ()
M112

  • Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)
LINING CEMENT 15 g liquid
Gc America Inc.
000108
In Commercial Distribution

  • 24548161329375 ()
  • 14548161329378 ()

  • Total Volume: 12 Milliliter
000108

  • Glass ionomer dental cement
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