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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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CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT AU-201-300 - 00817302022278

HCY (Homocysteine) w/ cal 1 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-201-300
In Commercial Distribution

  • 00817302022278 ()

  • Total Volume: 3 Milliliter
  • Total Volume: 9 Milliliter
  • Kit contains 1 R1, 1 R2, CAL 0.0µmol/L & CAL 28µmol/L and 1 package insert
  • Total Volume: 50 Milliliter
AU-201-300

  • Homocysteine IVD, kit, spectrophotometry

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 SERUM CAL KIT Product No. 28200 - 00817302022261

Serum Calibrator
CAROLINA LIQUID CHEMISTRIES CORPORATION
28200
Not in Commercial Distribution

  • 00817302022261 ()

  • Total Volume: 5 Milliliter
  • Kit contains 6 ca-5 bottles, 1 reagent package insert and 1 setpoint package insert
28200

  • Glucose/ketone/lipid profile IVD, calibrator

CAROLINA LIQUID CHEMISTRIES CORP.™ LD-L REAGENT CC205 - 00817302022254

LDH (Lactate Dehydrogenase) 2 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC205
In Commercial Distribution

  • 00817302022254 ()

  • Kit contains 2 reagent cartridges and 1 package insert
  • Total Volume: 60 Milliliter
  • Total Volume: 4 Milliliter
CC205

  • Lactate dehydrogenase (LDH) multiple isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® LDH RGT. KIT AU-205 - 00817302022247

LDH (Lactate Dehydrogenase) 3 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-205
In Commercial Distribution

  • 00817302022247 ()

  • Total Volume: 60 Milliliter
  • Total Volume: 9 Milliliter
  • Kit contains 3 R1, 3 R2 and 1 package insert
AU-205

  • Lactate dehydrogenase (LDH) multiple isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® LDH RGT. KIT BL-205 - 00817302022230

LDH (Lactate Dehydrogenase) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL205
In Commercial Distribution

  • 00817302022230 ()

  • Total Volume: 25 Milliliter
  • Kit contains 3 R1, 3 R2 and 1 package insert
  • Total Volume: 5 Milliliter
BL205

  • Lactate dehydrogenase (LDH) multiple isoenzyme IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CAL SET PART# 7-H7541-CAL - 00817302022179

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

CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CTL SET PART# 7-H7541-CTL - 00817302022162

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

CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 - 00817302022155

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

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HbA1c RGT KIT Pt No. ST300 - 00817302022148

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

CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 - 00817302022131

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
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