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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 - 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

D3 - 30014613330400

Influenza B DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013200.V2-BULK
In Commercial Distribution

  • 30014613330400 ()
01-013200.V2-BULK

  • Influenza B virus 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 - 30014613330325

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 - 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 - 30014613330301

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 - 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

D3 Ultra - 30014613330288

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

Diazyme - 00817089021662

No Description
DIAZYME LABORATORIES, INC.
DZ131B-K
In Commercial Distribution

  • 00817089021662 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

Diazyme - 00817089020986

No Description
DIAZYME LABORATORIES, INC.
DZ131A-KY1
In Commercial Distribution

  • 00817089020986 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

Diazyme - 00817089020979

No Description
DIAZYME LABORATORIES, INC.
DZ131A-KB1
In Commercial Distribution

  • 00817089020979 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

Diazyme - 00817089020351

No Description
DIAZYME LABORATORIES, INC.
DZ131A-K
In Commercial Distribution

  • 00817089020351 ()


  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

IgA control slides - B502BSB36850

IgA Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB36850 ()
BSB 3685

  • Immunoglobulin A antibody (anti-IgA) IVD, control

IgA / FITC control slides - B502BSB3005CS0

IgA / FITC control
BIO SB, INC.
control slides, 5
In Commercial Distribution

  • B502BSB3005CS0 ()
BSB 3005-CS

  • Immunoglobulin A antibody (anti-IgA) IVD, control

CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit - 00817302022315

Lp (a) Lipoprotein BL-204B
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL-204B
In Commercial Distribution

  • 00817302022315 ()

  • Kit contains 2 R1 and 2 R2 bottles
  • Total Volume: 18 Milliliter
  • Total Volume: 7 Milliliter
BL-204B

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
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