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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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KIT, OPTIGEN® Food 29 (20T)
Minaris Medical America, Inc.
85067
In Commercial Distribution

  • 00813382010013 ()
85067

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
Licox® Complete Brain Tunnelling Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IT2
Not in Commercial Distribution

  • M273IT21 ()
  • 10381780041207 ()

  • 130 mm x 35 mm x 313 mm
IT2

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IP2P
Not in Commercial Distribution

  • M273IP2P1 ()
  • 10381780041191 ()

  • 130 mm x 35 mm x 313 mm
IP2P

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IP1P
Not in Commercial Distribution

  • M273IP1P1 ()
  • 10381780041184 ()

  • 130 mm x 35 mm x 313 mm
IP1P

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM3ST
Not in Commercial Distribution

  • M273IM3ST1 ()
  • 10381780041177 ()

  • 130 mm x 50 mm x 313 mm
IM3ST

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM3S
Not in Commercial Distribution

  • M273IM3S1 ()
  • 10381780041160 ()

  • 130 mm x 35 mm x 313 mm
IM3S

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM2S
Not in Commercial Distribution

  • M273IM2S1 ()
  • 10381780041153 ()

  • 130 mm x 35 mm x 313 mm
IM2S

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IM1S
Not in Commercial Distribution

  • M273IM1S1 ()
  • 10381780041146 ()

  • 130 mm x 35 mm x 313 mm
IM1S

  • Intracerebral sensor catheter, short-term
Licox® Combined Oxygen and Temperature Probe
GMS, Gesellschaft für medizinische Sondentechnik mbH
CC1P1
Not in Commercial Distribution

  • M273CC1P11 ()
  • 10381780041078 ()

  • 130 mm x 35 mm x 313 mm
CC1P1

  • Intracerebral sensor catheter, short-term
Licox® Oxygen Probe
GMS, Gesellschaft für medizinische Sondentechnik mbH
CC1SB
Not in Commercial Distribution

  • M273CC1SB1 ()
  • 10381780041061 ()

  • 130 mm x 35 mm x 313 mm
CC1SB

  • 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
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