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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 - 30014613330431

Adeno DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013402.V2
In Commercial Distribution

  • 30014613330431 ()
01-013402.V2

  • Adenovirus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330424

RSV DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013302.V2
In Commercial Distribution

  • 30014613330424 ()
01-013302.V2

  • Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330394

Influenza A DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013102.V2
In Commercial Distribution

  • 30014613330394 ()
01-013102.V2

  • Influenza A virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330387

Influenza A DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013100.V2-BULK
In Commercial Distribution

  • 30014613330387 ()
01-013100.V2-BULK

  • Influenza A virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330370

DFA Respiratory Virus Screening Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013010.V2
In Commercial Distribution

  • 30014613330370 ()
01-013010.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330363

DFA Respiratory Virus Screening Reagent - Bulk
DIAGNOSTIC HYBRIDS, INC.
01-013000.V2-BULK
In Commercial Distribution

  • 30014613330363 ()
01-013000.V2-BULK

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330356

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 - 30014613330349

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

D3 Ultra - 30014613330318

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 - 30014613330295

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
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