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 Class Implantable

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5 panel test cup, AMP/BZO/COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-5AB-W
Not in Commercial Distribution

  • 00816565020205 ()
IMCA-5AB-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8CM5
Not in Commercial Distribution

  • 00816565020281 ()
IMCA-8CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8BB
Not in Commercial Distribution

  • 00816565020267 ()
IMCA-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9CM5
Not in Commercial Distribution

  • 00816565020335 ()
IMCA-9CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (COC/THC)+(OXY/MDMA)+AMP+BZO+MET1000+MTD+OPI2000 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9A
Not in Commercial Distribution

  • 00816565020328 ()
IMCA-9A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 panel test cup, (BZO/BAR)+(OXY/MDMA)+(PCP/AMP)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-10M5
Not in Commercial Distribution

  • 00816565020359 ()
IMCA-10M5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 panel test cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(PCP/AMP)+MTD+OXY+PPX with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-11OP
Not in Commercial Distribution

  • 00816565020311 ()
IMCA-11OP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-12BUP
Not in Commercial Distribution

  • 00816565020298 ()
IMCA-12BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests (for Impact Employees)
AMEDITECH INC.
IMCA-9CM5-5
Not in Commercial Distribution

  • 00816565020342 ()
IMCA-9CM5-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 panel test cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP1000)+BUP with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-13M
Not in Commercial Distribution

  • 00816565020304 ()
IMCA-13M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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