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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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HCY (Homocysteine) Level 2 control 6 x 5 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC052
In Commercial Distribution

  • 00817302020106 ()

  • Total Volume: 5 Milliliter
  • Kit contains 6 control bottles and 1 package insert
CC052

  • Homocysteine IVD, control
HCY (Homocysteine) Level 1 control 6 x 5 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC051
In Commercial Distribution

  • 00817302020090 ()

  • Total Volume: 5 Milliliter
  • Kit contains 6 control bottles and 1 package insert
CC051

  • Homocysteine IVD, control
HbA1c (Hemoglobin A1c) w/ lysis buffer 2 x 90 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC300
In Commercial Distribution

  • 00817302020083 ()

  • Total Volume: 5.5 Milliliter
  • Total Volume: 25 Milliliter
  • Total Volume: 7 Milliliter
  • Total Volume: 22 Milliliter
  • Kit contains 2 cartridges which contain R1, R2 & R1B, 2 Lysis buffer bottles 1 package insert and 2 user defined parameters
CC300

  • Glycated haemoglobin (HbA1c) IVD, reagent
HbA1c (Hemoglobin A1c Direct) 1 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-300
In Commercial Distribution

  • 00817302020076 ()

  • Total Volume: 30 Milliliter
  • Total Volume: 10 Milliliter
  • Total Volume: 15 Milliliter
  • Kit contains 1 R1, 1 R2, 1 R1B, 2 Lysis Buffer (B1), and 1 package insert
  • Total Volume: 23 Milliliter
AU-300

  • Glycated haemoglobin (HbA1c) IVD, reagent
CYST (Cystatin-C) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC691
In Commercial Distribution

  • 00817302020069 ()

  • Total Volume: 4.5 Milliliter
  • Total Volume: 20 Milliliter
  • Kit contains 2 cartridges which contain R1 and R2 and 1 package insert
CC691

  • Cystatin C IVD, kit, enzyme immunoassay (EIA)
CREAu (Creatinine, Urine) only
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL343
In Commercial Distribution

  • 00817302020052 ()

  • Kit contains 3 R1, 3 R2 & 1 package insert
  • Total Volume: 10 Milliliter
  • Total Volume: 25 Milliliter
BL343

  • Creatine IVD, kit, spectrophotometry
CREA (Creatinine)
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL243
In Commercial Distribution


  • Kit contains 3 R1, 3 R2 & 1 package insert
  • Total Volume: 25 Milliliter
  • Total Volume: 10 Milliliter
BL243

  • Creatinine IVD, kit, spectrophotometry
CREA (Creatinine) 4 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST243
In Commercial Distribution

  • 00817302020038 ()

  • Total Volume: 45 Milliliter
  • Kit contains 4 R1, 4 R2 & 1 package insert
  • Total Volume: 17 Milliliter
ST243

  • Creatine IVD, kit, spectrophotometry
HCY (Homocysteine) w/ cal 1X 150 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-201
In Commercial Distribution

  • 00817302020021 ()

  • Kit contains 1 R1, 1 R2, CAL 0.0µmol/L & CAL 28µmol/L and 1 package insert
  • Total Volume: 30 Milliliter
  • Total Volume: 3 Milliliter
  • Total Volume: 5 Milliliter
AU-201

  • Homocysteine IVD, kit, spectrophotometry
HCY (Homocysteine) w/ cal 1X 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL201
In Commercial Distribution

  • 00817302020014 ()

  • Total Volume: 4 Milliliter
  • Total Volume: 3 Milliliter
  • Kit contains 1 R1, 1 R2, CAL 0.0µmol/L & CAL 28µmol/L and 1 package insert
  • Total Volume: 25 Milliliter
BL201

  • Homocysteine IVD, kit, spectrophotometry
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