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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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Thyretain - 30014613331544

THYR LUCIFERASE REAGENT SET
DIAGNOSTIC HYBRIDS, INC.
40-3000.V2
In Commercial Distribution

  • 30014613331544 ()
40-3000.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331520

THYRETAIN MEDIA SET
DIAGNOSTIC HYBRIDS, INC.
40-2000.V2
In Commercial Distribution

  • 30014613331520 ()
40-2000.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331506

THYRETAIN CELLS AND Control SET
DIAGNOSTIC HYBRIDS, INC.
40-1025.V2
In Commercial Distribution

  • 30014613331506 ()
40-1025.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

Thyretain - 30014613331483

THYRETAIN GROWTH MEDIUM
DIAGNOSTIC HYBRIDS, INC.
40-100200.V2
In Commercial Distribution

  • 30014613331483 ()
40-100200.V2

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, bioassay

D3 Ultra - 30014613330479

Parainfluenza 3 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013702.V2
In Commercial Distribution

  • 30014613330479 ()
01-013702.V2

  • Human parainfluenza virus 3 antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330462

Parainfluenza 2 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013602.V2
In Commercial Distribution

  • 30014613330462 ()
01-013602.V2

  • Human parainfluenza virus 2 antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330455

Parainfluenza 1 DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013502.V2
In Commercial Distribution

  • 30014613330455 ()
01-013502.V2

  • Human parainfluenza virus 1 antigen IVD, kit, fluorescent immunoassay

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 - 30014613330417

Influenza B DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013202.V2
In Commercial Distribution

  • 30014613330417 ()
01-013202.V2

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay
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