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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.® HbA1c REAGENT CC300 - 00817302020083

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

CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT AU-300 - 00817302020076

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

CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691 - 00817302020069

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)

CAROLINA LIQUID CHEMISTRIES CORP.® UCREA RGT. KIT BL-343 - 00817302020052

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

Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set - 00817302020045

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

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CREATININE REAGENT KIT - 00817302020038

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

CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT AU-201 - 00817302020021

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

CAROLINA LIQUID CHEMISTRIES CORP. ® HCY RGT. KIT BL-201 - 00817302020014

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

CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910 - 00817302024517

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

CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213 - 00817302024180

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

CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621 - 00817302024135

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

CAROLINA LIQUID CHEMISTRIES CORP.® COCM COCAINE CC413 - 00817302021264

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),

CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424 - 00817302020847

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)

CAROLINA LIQUID CHEMISTRIES CORP.® CREA CREATININE REAGENT CC243 - 00817302020557

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

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET - 00817302020175

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

CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 - 00817302020816

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)

CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT DT209 - 00817302024395

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

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HDL RGT KIT Product No. ST616 - 00817302022186

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

CAROLINA LIQUID CHEMISTRIES CORP.® PCP PHENCYCLIDINE CC414 - 00817302021660

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)

CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 - 00817302021363

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
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