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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) 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
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
Lp(a) (Lipoprotein (a) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC204-100-D
In Commercial Distribution

  • 00817302020151 ()

  • Kit contains 2 reagent cartridges 1 reagent package insert and 1 user defined parameters package insert
  • Total Volume: 4 Milliliter
  • Total Volume: 15 Milliliter
CC204-100-D

  • LDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA)
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)
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
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)
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
PRE-OP KIT 2
MEDLINE INDUSTRIES, INC.
DYKS1088
In Commercial Distribution

  • 10888277762213 ()
DYKS1088

  • General surgical procedure kit, non-medicated, single-use
ANGIO PACK #2
MEDLINE INDUSTRIES, INC.
DYNJ39185B
In Commercial Distribution

  • 10888277800755 ()
  • 40888277800756 ()
DYNJ39185B

  • General surgical procedure kit, non-medicated, reusable
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