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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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Lp(a) (Lipoprotein (a) 3 x 400 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-204-D
In Commercial Distribution

  • 00817302020144 ()

  • Total Volume: 15 Milliliter
  • Total Volume: 45 Milliliter
  • Kit contains 3 R1 bottles, 3 R2 bottles and 1 package insert
AU-204-D

  • LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)
Lp(a) (Lipoprotein (a) 2 x 130 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL204
In Commercial Distribution

  • 00817302020137 ()

  • Total Volume: 7 Milliliter
  • Kit contains 2 R1 bottles, 2 R2 bottles and 1 package insert
  • Total Volume: 18 Milliliter
BL204

  • LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)
HCY (Homocysteine) w/ cal 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC202
In Commercial Distribution

  • 00817302020120 ()

  • Total Volume: 5 Milliliter
  • Total Volume: 2.5 Milliliter
  • Total Volume: 20 Milliliter
  • Kit contains 2 HCY Reagent cartridges, 1 C1 Calibrator, 1 C2 Calibrator,1 Reagent Kit Package insert and 2 User Defined Parameters
CC202

  • Homocysteine IVD, control
HCY (Homocysteine) Level 3 control 6 x 5 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC053
In Commercial Distribution

  • 00817302020113 ()

  • Total Volume: 5 Milliliter
  • Kit contains 6 control bottles and 1 package insert
CC053

  • Homocysteine IVD, control
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 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
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
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
ISE SELECTIVITY CHECK
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT910
In Commercial Distribution

  • 00817302024517 ()

  • Total Volume: 4 Milliliter
  • Kit contains 5 R1 bottles and 5 R2 bottles
  • Weight: 0.18 Gram
DT910

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Triglycerides (TRIG)
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL213
In Commercial Distribution

  • 00817302024180 ()

  • Total Volume: 25 Milliliter
  • Kit contains 3 R1 bottles and 3 R2 bottles
  • Total Volume: 5 Milliliter
BL213

  • Triglyceride IVD, kit, spectrophotometry
Lipase Reagent (LIP) w/ Calibrator
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-621
In Commercial Distribution

  • 00817302024135 ()

  • Kit contains 3 R1 bottles 3 R2 bottles and 1 calibrator
  • Total Volume: 5 Milliliter
  • Total Volume: 1 Milliliter
  • Total Volume: 17 Milliliter
AU-621

  • Lipase IVD, kit, spectrophotometry
COCM (Cocaine)CX/LX/DXC 1 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC413
Not in Commercial Distribution

  • 00817302021264 ()

  • Total Volume: 18 Milliliter
  • Kit contains 1 reagent cartridge and 1 package insert
  • Total Volume: 65 Milliliter
CC413

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
BUP (Buprenorphine)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-424
In Commercial Distribution

  • 00817302020847 ()

  • Total Volume: 23 Milliliter
  • Total Volume: 60 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
AU-424

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
CREA (Creatinine) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC243
In Commercial Distribution

  • 00817302020557 ()

  • Total Volume: 18 Milliliter
  • Total Volume: 85 Milliliter
  • Kit contains 2 reagent cartridges and 1 package insert
CC243

  • Creatine IVD, kit, spectrophotometry
Vitamin D-direct w/ cal 1 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST500
In Commercial Distribution

  • 00817302020175 ()

  • Total Volume: 3 Milliliter
  • Kit contains 1 R1, 1 R2, 1 R3, 1 R4 (diluent), 1 each calibrators, C1, C2, C3, C4,& C5 and 1 package insert.
  • Total Volume: 7.5 Milliliter
  • Total Volume: 17 Milliliter
  • Total Volume: 13 Milliliter
ST500

  • Multiple form 25-hydroxy Vitamin D IVD, calibrator
  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
6-AM (6-Acetylmorphine)
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT425
In Commercial Distribution

  • 00817302020816 ()

  • Total Volume: 29 Milliliter
  • Total Volume: 59 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT425

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
Gamma Glutamyl Transferase (GGT) Reagent
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT209
In Commercial Distribution

  • 00817302024395 ()

  • Total Volume: 17 Milliliter
  • Total Volume: 63 Milliliter
  • Kit contains 4 R1 bottles and 4 R2 bottles
DT209

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
HDLD (HDL Cholesterol Direct) w/ cal 2 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST616
In Commercial Distribution

  • 00817302022186 ()

  • Total Volume: 3 Milliliter
  • Kit contians 2 R1, 2 R2, 1 cal 3, 1 calibrator package insert and 1 reagent package insert
  • Total Volume: 16 Milliliter
  • Total Volume: 44 Milliliter
ST616

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
PCP (Phencyclidine)CX/LX/DXC 1 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC414
Not in Commercial Distribution

  • 00817302021660 ()

  • Total Volume: 18 Milliliter
  • Total Volume: 65 Milliliter
  • Kit contains 1 reagent cartridge and 1 package insert
CC414

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
ETHA (Alcohol) w/ cal 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST321
In Commercial Distribution

  • 00817302021363 ()

  • Total Volume: 5 Milliliter
  • Kit contains 2 R1, 2 R2 bottles, 1 Calibrator and 1 package insert
  • Total Volume: 33 Milliliter
  • Total Volume: 13 Milliliter
ST321

  • Ethanol (ETOH) IVD, kit, spectrophotometry
RF (Rheumatoid Factor) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-629
In Commercial Distribution

  • 00817302020991 ()

  • Total Volume: 5 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 19 Milliliter
AU-629

  • Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
Uric Acid (URIC)
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC212
In Commercial Distribution

  • 00817302024258 ()

  • Kit contains 2 cartridges
  • Total Volume: 90 Milliliter
  • Total Volume: 15 Milliliter
CC212

  • Uric acid IVD, kit, spectrophotometry
Alanine Aminotransferase (ALT) (GPT) Reagent
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT240
In Commercial Distribution

  • 00817302024456 ()

  • Kit contains 4 R1 bottles and 4 R2 bottles
  • Total Volume: 17 Milliliter
  • Total Volume: 63 Milliliter
DT240

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
ACID WASHING SOLUTION (ACID WASH)
CAROLINA LIQUID CHEMISTRIES CORPORATION
100262
In Commercial Distribution

  • 00817302024012 ()

  • Total Volume: 500 Milliliter
  • Kit contains 2 R1 bottles
100262

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry
METD (Methadone) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT415
In Commercial Distribution

  • 00817302021868 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT415

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Hydrocodone
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC442
In Commercial Distribution

  • 00817302021400 ()

  • Total Volume: 37.5 Milliliter
  • Kit contains 1 R1 and 1 R2 bottles and 1 package insert
  • Total Volume: 100 Milliliter
CC442

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
GLU3 (Glucose) - CX3 Reagent 1 x 500 mL
CAROLINA LIQUID CHEMISTRIES CORPORATION
88807
In Commercial Distribution

  • 00817302020656 ()

  • Total Volume: 500 Milliliter
  • Kit contains 1 R1 and 1 package insert
88807

  • Glucose IVD, kit, spectrophotometry
Vitamin D-direct control 2 x 2 mL (2 lev)
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST501
In Commercial Distribution

  • 00817302020168 ()

  • Kit contains 2 Control 1 bottles, 2 Control 2 bottles and 1 package insert
  • Total Volume: 2 Milliliter
ST501

  • Multiple form 25-hydroxy Vitamin D IVD, control
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