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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 - 30014613311058

Lyra Direct CDIFF Assay
QUIDEL CORPORATION
Direct C. difficile Assay
In Commercial Distribution

  • 30014613311058 ()
M105

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Solana - 30014613336150

Solana C. difficile Assay
DIAGNOSTIC HYBRIDS, INC.
M307
In Commercial Distribution

  • 30014613336150 ()
M307

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert C. difficile - 07332940000059

Xpert C. difficile test; 120 test kit
CEPHEID
GXCDIFFICILE-120
In Commercial Distribution

  • 07332940000059 ()
GXCDIFFICILE-120

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert C. difficile/Epi - 07332940000042

Xpert C. difficile/Epi kit; 120 test kit
CEPHEID
GXCDIFF/EPI-120
In Commercial Distribution

  • 07332940000042 ()
GXCDIFF/EPI-120

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert C. difficile - 07332940000035

Xpert C. difficile test; 10 test kit
CEPHEID
GXCDIFFICILE-10
In Commercial Distribution

  • 07332940000035 ()
GXCDIFFICILE-10

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Xpert C. difficile/Epi - 07332940000028

Xpert C. difficile/Epi test; 10 test kit
CEPHEID
GXCDIFF/EPI-10
In Commercial Distribution

  • 07332940000028 ()
GXCDIFF/EPI-10

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ C.difficile Sample Prep Kit - 20816101025613

No Description
DIASORIN MOLECULAR LLC
MOL5290
In Commercial Distribution

  • 20816101025613 ()
MOL5290

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ C. difficile Positive Control Pack - 20816101025606

No Description
DIASORIN MOLECULAR LLC
MOL2960
In Commercial Distribution

  • 20816101025606 ()
MOL2960

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ C. difficile Direct - 20816101025590

No Description
DIASORIN MOLECULAR LLC
MOL2950
In Commercial Distribution

  • 20816101025590 ()
MOL2950

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Simplexa™ C. difficile Universal Direct - 20816101025583

No Description
DIASORIN MOLECULAR LLC
MOL2975
In Commercial Distribution

  • 20816101025583 ()
MOL2975

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
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