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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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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
CRPhsWR (C-Reactive Protein high sensitivity Wide Range) control
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC049
In Commercial Distribution

  • 00817302022100 ()

  • Total Volume: 3 Milliliter
  • Kit contains 1 control 1, 1 control 2 and 1 package insert
CC049

  • Glucose IVD, control
CRPhsWR (C-Reactive Protein high sensitivity Wide Range) 2 x 220 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC646
Not in Commercial Distribution

  • 00817302022094 ()

  • Total Volume: 40.5 Milliliter
  • Kit contains 2 reagent cartridges, 1 package insert and 2 user defined parameters
  • Total Volume: 21 Milliliter
CC646

  • C-reactive protein (CRP) IVD, kit, spectrophotometry
CRPhsWR (C-Reactive Protein high sensitivity Wide Range) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC645
Not in Commercial Distribution

  • 00817302022087 ()

  • Kit contains 2 reagent cartridges, 1 package insert and 2 user defined parameters
  • Total Volume: 11 Milliliter
  • Total Volume: 20.5 Milliliter
CC645

  • C-reactive protein (CRP) IVD, kit, spectrophotometry
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