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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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Status Flu Controls - 10743816001423

Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution

  • 10743816001423 ()
BSP-510C-02

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control

BioSign Flu Controls - 10743816001492

BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution

  • 10743816001492 ()
BSP-510C-03

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR - 00840828100847

320 P37,SY,2L,2LD,TV & LT COM TIED,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-991-144
In Commercial Distribution

  • 00840828100847 ()
229

  • Electrical mains power extension cable

Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges - 04987270231753

No Description
FUJIREBIO INC.
231753
In Commercial Distribution

  • 04987270231753 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay

Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges - 04987270231432

No Description
FUJIREBIO INC.
231432
In Commercial Distribution

  • 04987270231432 ()

  • Number of tests per kit: 42


  • Amyloid B component IVD, kit, chemiluminescent immunoassay

N Latex ADNase B (USA) - 00630414285054

Quantitative determination of ADNase B in human serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873691
In Commercial Distribution

  • 00630414285054 ()
OWTI15

  • Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, reagent

CD39 [EPR20627] - 00847627030580

No Description
BIOCARE MEDICAL LLC
AVI3283G
In Commercial Distribution

  • 00847627030580 ()


  • Niemann-Pick disease (SMPD1-associated) IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007122

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 3
In Commercial Distribution

  • 00859882007122 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007115

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 2
In Commercial Distribution

  • 00859882007115 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Ultrio Plus Assay - 00859882007092

No Description
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 4
In Commercial Distribution

  • 00859882007092 ()


  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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