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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 Methadone Metabolite EDDP - 00817302022933

Methadone Metabolite Enzyme Immunoassay
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST326B
In Commercial Distribution

  • 00817302022933 ()

  • Total Volume: 33 Milliliter
  • Total Volume: 13 Milliliter
  • Kit contains 3 R1 bottles and 3 R2 bottles
ST326B

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660 - 00817302022704

UIBC (Unsaturated Iron Binding Capacity) w/ cal 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC660
In Commercial Distribution

  • 00817302022704 ()

  • Total Volume: 32 Milliliter
  • Total Volume: 8 Milliliter
  • Kit contains 2 filled reagent cartridges, 1 filled UIBC Calibrator bottle, 2 UIBC User Defined Parameters, 1 UIBC Calibrator package insert, and 1 UIBC reagent package insert
  • Total Volume: 10 Milliliter
CC660

  • Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

Carolina Liquid Chemistries Methadone Metabolite EDDP - 00817302022575

Methadone Metabolite Enzyme Immunoassay
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST426B
In Commercial Distribution

  • 00817302022575 ()

  • Kit contains 3 R1 bottles and 3 R2 bottles
  • Total Volume: 26 Milliliter
  • Total Volume: 63 Milliliter
ST426B

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

Carolina Liquid Chemistries CRPhsWR - 00817302022445

CRPhsWR (C-Reactive Protein)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-645B
In Commercial Distribution

  • 00817302022445 ()

  • Kit contains 3 R1 bottles and 3 R2 bottles
  • Total Volume: 18 Milliliter
AU-645B

  • C-reactive protein (CRP) IVD, reagent

Carolina Liquid Chemistries CRPhsWR - 00817302022421

CRPhsWR (C-Reactive Protein)
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT645
In Commercial Distribution

  • 00817302022421 ()

  • Total Volume: 10 Milliliter
  • Kit contains 3 R1 bottles and 3 R2 bottles
DT645

  • C-reactive protein (CRP) IVD, reagent

CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit - 00817302022315

Lp (a) Lipoprotein BL-204B
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL-204B
In Commercial Distribution

  • 00817302022315 ()

  • Kit contains 2 R1 and 2 R2 bottles
  • Total Volume: 18 Milliliter
  • Total Volume: 7 Milliliter
BL-204B

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428 - 00817302022292

Fentanyl Enzyme Immunoassay
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT428
In Commercial Distribution

  • 00817302022292 ()

  • Kit contains 2 R1 bottles and 2 R2 bottles
  • Total Volume: 30 Milliliter
  • Total Volume: 10 Milliliter
DT428

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)

CAROLINA LIQUID CHEMISTRIES CORP.® HCY RGT. KIT Product No. ST201 - 00817302022285

HCY (Homocysteine) w/ cal 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST201
In Commercial Distribution

  • 00817302022285 ()

  • Total Volume: 35 Milliliter
  • Total Volume: 3 Milliliter
  • Kit contains 3 R1, 1 R2, CAL 0.0µmol/L & CAL 28µmol/L and 1 package insert3
  • Total Volume: 6.5 Milliliter
ST201

  • Homocysteine IVD, kit, spectrophotometry
  • Homocysteine IVD, calibrator

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
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