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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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HDLD W/CALIBRATOR, 2 X 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC615
In Commercial Distribution

  • 00817302022216 ()

  • Kit contains 2 reagent cartridges with R1 and R2, 1 cal 3, 1 calibrator package insert, 1 reagent package insert and 1 user defined parameters
  • Total Volume: 20 Milliliter
  • Total Volume: 60 Milliliter
  • Total Volume: 3 Milliliter
CC615

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
HDLD (High Density Lipoprotein Direct) w/ cal 3 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-616
In Commercial Distribution

  • 00817302022209 ()

  • Total Volume: 60 Milliliter
  • Kit contians 3 R1, 3 R2, 1 cal 3, 1 calibrator package insert and 1 reagent package insert
  • Total Volume: 3 Milliliter
  • Total Volume: 20 Milliliter
AU-616

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
HDLD (High Density Lipoprotein Direct) w/ cal 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL616
In Commercial Distribution

  • 00817302022193 ()

  • Kit contians 3 R1, 3 R2, 1 cal 3, 1 calibrator package insert and 1 reagent package insert
  • Total Volume: 25 Milliliter
  • Total Volume: 3 Milliliter
  • Total Volume: 2 Milliliter
BL616

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
HbA1c (Hemoglobin A1c) calibrator
CAROLINA LIQUID CHEMISTRIES CORPORATION
7-H7541-CAL
In Commercial Distribution

  • 00817302022179 ()

  • Total Volume: 0.5 Milliliter
  • Kit contains 1 cal 1, 1 cal 2, 1 cal 3, 1 cal 4 and 1 package insert
7-H7541-CAL

  • Voriconazole therapeutic drug monitoring IVD, control
HbA1c (Hemoglobin A1c) control
CAROLINA LIQUID CHEMISTRIES CORPORATION
7-H7541-CTL
In Commercial Distribution

  • 00817302022162 ()

  • Total Volume: 0.5 Milliliter
  • Kit contains 1 control 1, 1 control 2 and 1 package insert
7-H7541-CTL

  • Glycated haemoglobin (HbA1c) IVD, control
HbA1c (Hemoglobin A1c Direct) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL300
In Commercial Distribution

  • 00817302022155 ()

  • Total Volume: 10 Milliliter
  • Kit contains 2 R1, 2 R2 and 1 package insert
  • Total Volume: 25 Milliliter
BL300

  • Free plasma haemoglobin IVD, kit, enzyme immunohistochemistry
HbA1c 2 x 150 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST300
In Commercial Distribution

  • 00817302022148 ()

  • Total Volume: 26 Milliliter
  • Kit contains 2 R1, 2 R2 and 1 package insert
  • Total Volume: 10 Milliliter
ST300

  • Free plasma haemoglobin IVD, kit, enzyme immunohistochemistry
FRUC (Fructosamine) w/ cal 2 x 40 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC612
In Commercial Distribution

  • 00817302022131 ()

  • Kit contains 2 Buffer bottles, 1 calibrator bottle, 2 empty reagent cartridges, 1 package insert and 2 user defined parameters
  • Total Volume: 2 Milliliter
  • Total Volume: 11 Milliliter
CC612

  • Fructosamine IVD, kit, spectrophotometry
FRUC (Fructosamine) w/ cal 3 x 80 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-612
Not in Commercial Distribution

  • 00817302022124 ()

  • Total Volume: 2 Milliliter
  • Kit contains 3 Buffer bottles, 1 calibrator bottle and 1 package insert
  • Total Volume: 11 Milliliter
AU-612

  • Fructosamine IVD, kit, spectrophotometry
FRUC (Fructosamine) Control
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC030
In Commercial Distribution

  • 00817302022117 ()

  • Total Volume: 2 Milliliter
  • Kit contains 1 control 1, 1 control 2 and 1 package insert
  • Total Volume: 3 Milliliter
CC030

  • Fructosamine IVD, control
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