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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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Lyra - 30014613311003

Lyra FLU A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M100
In Commercial Distribution

  • 30014613311003 ()
M100

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

Solana - 30014613336068

Solana Infulenza A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M300
In Commercial Distribution

  • 30014613336068 ()
M300

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

Xpert Xpress Flu - 07332940006044

Xpert Xpress Flu kit; 10 test kit
CEPHEID
XPRSFLU-10
In Commercial Distribution

  • 07332940006044 ()
XPRSFLU-10

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

Xpert Flu - 07332940001070

Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

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

Bausch + Lomb - 00757770411610

FCP INCUS WIRE CLOSURE MCGEE
Bausch & Lomb Incorporated
N1685 D 1
In Commercial Distribution

  • 00757770411610 ()
N1685 D 1

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry

Bausch + Lomb - 00757770426546

FORCEPS HARTMAN
Bausch & Lomb Incorporated
N0982
In Commercial Distribution

  • 00757770426546 ()
N0982

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry

Bausch + Lomb - 00757770420636

FCP HARTMAN-HERZFELD HORIZ OPN
Bausch & Lomb Incorporated
N0970
In Commercial Distribution

  • 00757770420636 ()
N0970

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry

Bausch + Lomb - 00757770417070

FORCEPS DUCKBILL
Bausch & Lomb Incorporated
N0958
In Commercial Distribution

  • 00757770417070 ()
N0958

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry

Bausch + Lomb - 00757770409068

FORCEPS TOBEY
Bausch & Lomb Incorporated
N0986
In Commercial Distribution

  • 00757770409068 ()
N0986

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry

Bausch + Lomb - 00757770408368

FCP HARTMAN-HERZFELD 3MM CUP
Bausch & Lomb Incorporated
N0965
In Commercial Distribution

  • 00757770408368 ()
N0965

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry
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