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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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SeCore™ DRB1, DRB3, DRB4, DRB5 Locus Sequencing Kit Group Specific Set - 00814695021734

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™ DRB1 Locus Sequencing Kit - 00814695021727

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™ C Locus Sequencing Kit - 00814695021710

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™ B Locus Sequencing Kit - Group Specific Set - 00814695021703

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™ A Locus Sequencing Kit - 00814695021697

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

Licox® - 10381780250340

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® - 10381780250333

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® - 10381780250319

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® - 10381780250289

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® - 10381780250210

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® - 10381780250180

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® - 10381780250173

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

Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin - 00893727002866

Refrigeration Test Yolk Buffer with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90129-20x5mL
In Commercial Distribution

  • 00893727002866 ()
  • 10893727002863 ()

  • Total Volume: 5 Milliliter
90129

  • IVF medium

Chang Medium D - 00893727002774

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
T105-500mL
In Commercial Distribution

  • 00893727002774 ()

  • Total Volume: 500 Milliliter
T105

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium in SITU - 00893727002767

Chang Medium in SITU
FUJIFILM IRVINE SCIENTIFIC, INC.
T104-500ML
In Commercial Distribution

  • 00893727002767 ()

  • Total Volume: 500 Milliliter
T104

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Amnio - 00893727002699

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
99473-500ML
In Commercial Distribution

  • 00893727002699 ()

  • Total Volume: 500 Milliliter
99473

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Amnio - 00893727002682

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
99473-100ML
In Commercial Distribution

  • 00893727002682 ()

  • Total Volume: 100 Milliliter
99473

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Marrow Bone Marrow Culture Medium with Gentamicin - 00893727002675

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91031-500mL
In Commercial Distribution

  • 00893727002675 ()

  • Total Volume: 500 Milliliter
91031

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Marrow Bone Marrow Culture Medium with Gentamicin - 00893727002668

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91031-100mL
In Commercial Distribution

  • 00893727002668 ()

  • Total Volume: 100 Milliliter
91031

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium in SITU - 00893727002484

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
T104-100ML
In Commercial Distribution

  • 00893727002484 ()

  • Total Volume: 100 Milliliter
T104

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium D - 00893727002477

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
T105-100mL
In Commercial Distribution

  • 00893727002477 ()

  • Total Volume: 100 Milliliter
T105

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

CHANG Medium® D with Antibiotics - 00893727002439

CHANG Medium® D with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
99404-100mL
In Commercial Distribution

  • 00893727002439 ()

  • Total Volume: 100 Milliliter
99404

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium MF with Gentamicin - 00893727002408

No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-100ML
In Commercial Distribution

  • 00893727002408 ()

  • Total Volume: 100 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Chang Medium BMC with Gentamicin - 00893727002392

Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-100ML
In Commercial Distribution

  • 00893727002392 ()

  • Total Volume: 100 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002217

Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-20X5mL
In Commercial Distribution

  • 00893727002217 ()
  • 10893727002214 ()

  • Total Volume: 5 Milliliter
90128

  • IVF medium

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002200

Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-100mL
In Commercial Distribution

  • 00893727002200 ()

  • Total Volume: 100 Milliliter
90128

  • IVF medium

SELECT BPA FREE PIT & FISSURE SEALANT KIT OPAQUE - D77819960101

Scott's Select BPA-Free Pit & Fissure Sealant kit is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces. BPA-Free Pit & Fissure Sealant is a light-cure pit and fissure sealant. It is a very low viscosity resin system with a white opaque color to help identify it's retention at recall appointments. It is contained in a direct delivery syringe system for quick and easy application. It is a diluted HDDMA-UDMA based resin with a white opaquer, a micro-fine silica particle and a photosensitive catalyst system. The Kit contains 4 x 1Gm Syringes of Sealant, 1 3mL bottle of Etchant and 10 applicator tips. Instructions for use and SDS available at https://www.scottsdental.com/pit-fissure-sealant-bpa-free.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-6010
In Commercial Distribution

  • D77819960101 ()

  • Total Volume: 3 Milliliter
  • Weight: 1 Gram
199-6010

  • Dental composite resin

CELL-DYN - 00380740017149

CELL-DYN RETIC PLUS CONTROL
ABBOTT LABORATORIES
08H62-01
In Commercial Distribution

  • 00380740017149 ()
08H6201

  • Reticulocyte count IVD, control

CELL-DYN - 00380740017118

CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-02
In Commercial Distribution

  • 00380740017118 ()
08H5902

  • Full blood count IVD, control

CELL-DYN - 00380740017101

CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-01
In Commercial Distribution

  • 00380740017101 ()
08H5901

  • Full blood count IVD, control

CELL-DYN - 00380740017095

CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-02
In Commercial Distribution

  • 00380740017095 ()
08H5802

  • Full blood count IVD, control

CELL-DYN - 00380740017088

CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-01
In Commercial Distribution

  • 00380740017088 ()
08H5801

  • Full blood count IVD, control

CELL-DYN - 00380740017071

CELL-DYN HemCal Plus Calibrator
ABBOTT LABORATORIES
08H57-01
In Commercial Distribution

  • 00380740017071 ()
08H5701

  • Full blood count IVD, calibrator

ARCHITECT - 00380740156060

ARCHITECT SHBG Controls
Abbott GmbH
08K2611
In Commercial Distribution

  • 00380740156060 ()
08K2611

  • Sex hormone binding globulin (SHBG) IVD, control

ARCHITECT - 00380740156053

ARCHITECT SHBG Calibrators
Abbott GmbH
08K2602
In Commercial Distribution

  • 00380740156053 ()
08K2602

  • Sex hormone binding globulin (SHBG) IVD, calibrator

Alinity - 00380740151294

ALINITY h-series HemCal
Abbott GmbH
04U7302
In Commercial Distribution

  • 00380740151294 ()
04U7302

  • Full blood count IVD, calibrator

Alinity - 00380740151287

ALINITY h-series CONTROL 29P
Abbott GmbH
04U7212
In Commercial Distribution

  • 00380740151287 ()
04U7212

  • Full blood count IVD, control

Alinity - 00380740151270

ALINITY h-series CONTROL 29P
Abbott GmbH
04U7206
In Commercial Distribution

  • 00380740151270 ()
04U7206

  • Full blood count IVD, control

ARCHITECT - 00380740138912

ARCHITECT B.R.A.H.M.S PCT Controls
Abbott GmbH
06P2210
In Commercial Distribution

  • 00380740138912 ()
06P2210

  • Procalcitonin (PCT) IVD, calibrator

ARCHITECT - 00380740138905

ARCHITECT B.R.A.H.M.S PCT Calibrators
Abbott GmbH
06P2201
In Commercial Distribution

  • 00380740138905 ()
06P2201

  • Procalcitonin (PCT) IVD, calibrator
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