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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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EDDP (Methadone Metabolites) 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT426
In Commercial Distribution

  • 00817302021448 ()

  • Total Volume: 20 Milliliter
  • Total Volume: 8 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT426

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
CRPhs (C-Reactive Protein high sensitivity) 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST645
In Commercial Distribution

  • 00817302022056 ()

  • Total Volume: 35 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
ST645

  • C-reactive protein (CRP) IVD, kit, spectrophotometry
LDH (Lactate Dehydrogenase) 4 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST205
In Commercial Distribution

  • 00817302022223 ()

  • Total Volume: 13.5 Milliliter
  • Total Volume: 53 Milliliter
  • Kit containts 4 R1, 4 R2 and 1 package insert
ST205

  • Lactate dehydrogenase (LDH) multiple isoenzyme IVD, reagent
XTSY (Ecstasy) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST323
In Commercial Distribution

  • 00817302021981 ()

  • Total Volume: 33 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 13 Milliliter
ST323

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
TBIL (Total Bilirubin) 2 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC228
In Commercial Distribution

  • 00817302020717 ()

  • Kit contains 2 reagent cartridges filled with reagents R1, R2 & R3 and 1 package inser
  • Total Volume: 11 Milliliter
  • Total Volume: 2 Milliliter
  • Total Volume: 90 Milliliter
CC228

  • Total bilirubin IVD, kit, spectrophotometry
CK (Creatine Kinase) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL207
In Commercial Distribution

  • 00817302020496 ()

  • Total Volume: 20 Milliliter
  • Total Volume: 5 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
BL207

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent
AMY (Amylase) 3 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-227
In Commercial Distribution

  • 00817302020298 ()

  • Kit contains 3 R1 bottles and 1 package insert
  • Total Volume: 20 Milliliter
AU-227

  • Amylase isoenzyme IVD, kit, spectrophotometry
Precision Flow Oxygen Assist Module, Nellcor UKIT South Africa
VAPOTHERM, INC.
OAM-NEL-UKIT-ZA
In Commercial Distribution

  • 00841737104315 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
Precision Flow Oxygen Assist Module, Masimo UKIT South Africa
VAPOTHERM, INC.
OAM-MAS-UKIT-ZA
In Commercial Distribution

  • 00841737104308 ()


  • Respiratory oxygen therapy physiologic monitor/gas regulator
  • Respiratory oxygen therapy pulse oximeter-regulator interface
  • Professional high-flow respiratory unit, humidifying, manual
Blood Culture Collection Kit, Baptist Medical Center South Only
AERO-MED, LLC
CA15850
Not in Commercial Distribution

  • 50885380164130 ()
  • 10885380164132 ()
CA15850

  • Phlebotomy kit
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