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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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OXYCODONE PLUS LEVEL 1
UTAK LABORATORIES, INC.
OXY+ 1 WB F QDCHANT
In Commercial Distribution

  • B800OXY1WBFQDCHANT5 ()
  • B800OXY1WBFQDCHANT0 ()

  • Total Volume: 2 Milliliter
OXY+ 1 WB F QDCHANT

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OXYCODONE PLUS LEVEL 1
UTAK LABORATORIES, INC.
OXY+ 1 S F QDCHANT
In Commercial Distribution

  • B800OXY1SFQDCHANT5 ()
  • B800OXY1SFQDCHANT0 ()

  • Total Volume: 2 Milliliter
OXY+ 1 S F QDCHANT

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OXAZEPAM GLUCURONIDE
UTAK LABORATORIES, INC.
OXA GLUC V2 U F HCMC
In Commercial Distribution

  • B800OXAGLUCV2UFHCMC5 ()
  • B800OXAGLUCV2UFHCMC0 ()

  • Total Volume: 2 Milliliter
OXA GLUC V2 U F HCMC

  • Multiple drugs of abuse IVD, control
OPIATES CALIBRATOR LEVEL 6
UTAK LABORATORIES, INC.
OPI U CAL 6 UNC
In Commercial Distribution

  • B800OPIUCAL6UNC5 ()
  • B800OPIUCAL6UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 6 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES CALIBRATOR LEVEL 4
UTAK LABORATORIES, INC.
OPI U CAL 4 UNC
In Commercial Distribution

  • B800OPIUCAL4UNC5 ()
  • B800OPIUCAL4UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 4 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES CALIBRATOR LEVEL 2
UTAK LABORATORIES, INC.
OPI U CAL 2 UNC
In Commercial Distribution

  • B800OPIUCAL2UNC5 ()
  • B800OPIUCAL2UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 2 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES CALIBRATOR LEVEL 1
UTAK LABORATORIES, INC.
OPI U CAL 1 UNC
In Commercial Distribution

  • B800OPIUCAL1UNC5 ()
  • B800OPIUCAL1UNC0 ()

  • Total Volume: 2 Milliliter
OPI U CAL 1 UNC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATES PLUS
UTAK LABORATORIES, INC.
OPIA+ WB WC
In Commercial Distribution

  • B800OPIAWBWC5 ()
  • B800OPIAWBWC0 ()

  • Total Volume: 5 Milliliter
OPIA+ WB WC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
OPIATE QC MIX
UTAK LABORATORIES, INC.
OPIA QC L FCCO
In Commercial Distribution

  • B800OPIAQCLFCCO5 ()
  • B800OPIAQCLFCCO0 ()

  • Total Volume: 25 Milliliter
OPIA QC L FCCO

  • Multiple-therapy therapeutic drug monitoring IVD, control
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Tunnelling Probe Kit
Integra LifeSciences Switzerland Sàrl
IT2
In Commercial Distribution

  • M272IT21 ()
  • 10381780250340 ()
  • 10381780041207 ()
IT2

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IP2P
In Commercial Distribution

  • M272IP2P1 ()
  • 10381780250333 ()
  • 10381780041191 ()
IP2P

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IP1P
In Commercial Distribution

  • M272IP1P1 ()
  • 10381780250319 ()
  • 10381780041184 ()
IP1P

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IM3ST
In Commercial Distribution

  • M272IM3ST1 ()
  • 10381780250289 ()
  • 10381780041177 ()
IM3ST

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Complete Brain Probe Kit
Integra LifeSciences Switzerland Sàrl
IM1S
In Commercial Distribution

  • M272IM1S1 ()
  • 10381780250210 ()
  • 10381780041146 ()
IM1S

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Oxygen Probe
Integra LifeSciences Switzerland Sàrl
CC1SB
In Commercial Distribution

  • M272CC1SB1 ()
  • 10381780250180 ()
  • 10381780041061 ()
CC1SB

  • Intracerebral sensor catheter, short-term
Licox® Brain Tissue Oxygen Monitoring- Combined Oxygen and Temperature Probe
Integra LifeSciences Switzerland Sàrl
CC1P1
In Commercial Distribution

  • M272CC1P11 ()
  • 10381780250173 ()
  • 10381780041078 ()
CC1P1

  • Intracerebral sensor catheter, short-term
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022892 ()
5341025D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022885 ()
22510D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022878 ()
22410D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022861 ()
22200D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022854 ()
5311025D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022847 ()
22300D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022830 ()
22110D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022823 ()
22000D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022519 ()
A11256

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021741 ()
5351025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021734 ()
5331025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021727 ()
5330025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021710 ()
5320025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021703 ()
5310025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021697 ()
5300025

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
DRUGS OF ABUSE PLUS LEVEL 4
UTAK LABORATORIES, INC.
DA+ 1 WB IMMUN
In Commercial Distribution

  • B800DA4WBIMMUN5 ()
  • B800DA4WBIMMUN0 ()

  • Total Volume: 1 Milliliter
DA+ 1 WB IMMUN

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 4
UTAK LABORATORIES, INC.
DA 4 WB F RIDH
In Commercial Distribution

  • B800DA4WBFRIDH5 ()
  • B800DA4WBFRIDH0 ()

  • Total Volume: 1 Milliliter
DA 4 WB F RIDH

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE PLUS LEVEL 3
UTAK LABORATORIES, INC.
DA+3 WB V2 IMMUN
In Commercial Distribution

  • B800DA3WBV2IMMUN5 ()
  • B800DA3WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+3 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE PLUS LEVEL 3
UTAK LABORATORIES, INC.
DA+ 3 WB IMMUN
In Commercial Distribution

  • B800DA3WBIMMUN0 ()

  • Total Volume: 1 Milliliter
DA+ 3 WB IMMUN

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DA 3 WB F RIDH
In Commercial Distribution

  • B800DA3WBFRIDH5 ()
  • B800DA3WBFRIDH0 ()

  • Total Volume: 1 Milliliter
DA 3 WB F RIDH

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE PLUS LEVEL 2
UTAK LABORATORIES, INC.
DA+2 WB V2 IMMUN
In Commercial Distribution

  • B800DA2WBV2IMMUN5 ()
  • B800DA2WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+2 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE PLUS LEVEL 2
UTAK LABORATORIES, INC.
DA+ 2 WB IMMUN
In Commercial Distribution

  • B800DA2WBIMMUN0 ()

  • Total Volume: 1 Milliliter
DA+ 2 WB IMMUN

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA 2 WB F RIDH
In Commercial Distribution

  • B800DA2WBFRIDH5 ()
  • B800DA2WBFRIDH0 ()

  • Total Volume: 1 Milliliter
DA 2 WB F RIDH

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA 2 V2 F WB TDHS
In Commercial Distribution

  • B800DA2V2FWBTDHS5 ()
  • B800DA2V2FWBTDHS0 ()

  • Total Volume: 5 Milliliter
DA 2 V2 F WB TDHS

  • Multiple drugs of abuse IVD, control
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