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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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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
MTS L/H KIT 1 -SOUTH AUSTIN HOSP PG
MEDLINE INDUSTRIES, INC.
60183292
In Commercial Distribution

  • 20193489050025 ()
  • 10193489050028 ()
60183292

  • Angiography kit
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
Personal Use Kit OC-Auto, for KPS South bay (HBRCTY)
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-KPS SB
In Commercial Distribution

  • 00816917020402 ()


  • Faecal occult blood IVD, reagent
No Description
BIOTECHNOLOGY INSTITUTE SL
RSMU
In Commercial Distribution

  • 08435389829126 ()


  • Dental implant suprastructure, temporary, preformed, reusable
No Description
BIOTECHNOLOGY INSTITUTE SL
RSMA
In Commercial Distribution

  • 08435389829119 ()


  • Dental implant suprastructure, temporary, preformed, reusable
No Description
BIOTECHNOLOGY INSTITUTE SL
RSME
In Commercial Distribution

  • 08435389829102 ()


  • Dental implant suprastructure, temporary, preformed, reusable
SINGLE LINE KIT WITH 03ML DEVICE FOR SOUTH SHORE HOSP
ICU MEDICAL, INC.
46099-05
In Commercial Distribution

  • 10840619045279 ()
  • 00840619045272 ()
46099-05

  • In-line arterial blood sampling set
Personal Use Kit OC-Auto, Custom Kit for CPL South East
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-CPLSE
In Commercial Distribution

  • 00816917023090 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, Custom Kit for Kaiser South Orange County
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-KPS OC1
In Commercial Distribution

  • 00816917022734 ()


  • Faecal occult blood IVD, reagent
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