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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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D3 Ultra DFA Respiratory Virus ID Set
DIAGNOSTIC HYBRIDS, INC.
01-010007.V2
In Commercial Distribution

  • 30014613330356 ()
01-010007.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Parainfluenza Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010006.V2
In Commercial Distribution

  • 30014613330349 ()
01-010006.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
De Ultra DFA Influenza A/Influenza B Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010004.V2
In Commercial Distribution

  • 30014613330325 ()
01-010004.V2

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA RSV Reagent Set
DIAGNOSTIC HYBRIDS, INC.
01-010003.V2
In Commercial Distribution

  • 30014613330318 ()
01-010003.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
No Description
DIAZYME LABORATORIES, INC.
DZ131B-K
In Commercial Distribution

  • 00817089021662 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
DIAZYME LABORATORIES, INC.
DZ131A-KY1
In Commercial Distribution

  • 00817089020986 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
No Description
DIAZYME LABORATORIES, INC.
DZ131A-KB1
In Commercial Distribution

  • 00817089020979 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
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