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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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CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA, CardioChek Plus or CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4747
In Commercial Distribution

  • 10381934747016 ()
  • 00381934747019 ()
REF 4747

  • Multiple lipid analyte IVD, kit, spectrophotometry
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424537
In Commercial Distribution

  • 00815381020727 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
MONOBIND, INC.
7325-300
In Commercial Distribution

  • 00816870020778 ()

  • Width: 7.75 Inch
7325-300A

  • C-peptide IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7375-300
In Commercial Distribution

  • 00816870022468 ()

  • Width: 7.75 Inch
7375-300B

  • C-peptide IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
7375-300
In Commercial Distribution

  • 00816870022451 ()

  • Width: 7.75 Inch
7375-300A

  • C-peptide IVD, kit, chemiluminescent immunoassay
No Description
AALTO SCIENTIFIC
K943M-5
In Commercial Distribution

  • B085K943M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K942M-5
In Commercial Distribution

  • B085K942M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K941M-5
In Commercial Distribution

  • B085K941M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K940M-5
In Commercial Distribution

  • B085K940M50 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
AALTO SCIENTIFIC
K919M-5
In Commercial Distribution

  • B085K919M50 ()


  • Total bilirubin IVD, control
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