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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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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
Alanine Aminotransferase (ALT) (GPT) Reagent
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT240
In Commercial Distribution

  • 00817302024456 ()

  • Kit contains 4 R1 bottles and 4 R2 bottles
  • Total Volume: 17 Milliliter
  • Total Volume: 63 Milliliter
DT240

  • Alanine aminotransferase (ALT) 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)
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),
THC (Cannabinoid)
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-410A
In Commercial Distribution

  • 00817302021745 ()

  • Total Volume: 23 Milliliter
  • Total Volume: 60 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
AU-410A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
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
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 Kaiser South Orange County
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-KPS OC1
In Commercial Distribution

  • 00816917022734 ()


  • Faecal occult blood IVD, reagent
1st Tier 6mm x 31G pen needles
OWEN MUMFORD USA INCORPORATED
AN 3590SPW
In Commercial Distribution

  • 00761059591856 ()
  • 00761059590859 ()
  • 00761059592853 ()
  • 00384703590007 ()

  • Length: 6 Millimeter
  • Needle Gauge: 31 Gauge


  • Autoinjector needle
1st Tier 5mm x 31g pen needles
OWEN MUMFORD USA INCORPORATED
AN 3550SPW
In Commercial Distribution

  • 00761059551850 ()
  • 00761059550853 ()
  • 00761059552857 ()
  • 00384703530003 ()

  • Length: 6 Millimeter
  • Needle Gauge: 31 Gauge


  • Autoinjector needle
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