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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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NA - 04546540432445

ZEISS PENTERO MICR. NAV.SYSTEM II KIT
Stryker Leibinger GmbH & Co. KG
7700-074-000
In Commercial Distribution

  • 04546540432445 ()
7700-074-000

  • Multi-purpose stereotactic surgery system

NA - 07613252516941

ZEISS NC4 MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-055-000
In Commercial Distribution

  • 07613252516941 ()
7700-055-000

  • Multi-purpose stereotactic surgery system

NA - 07613252516934

LEICA MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-065-000
In Commercial Distribution

  • 07613252516934 ()
7700-065-000

  • Multi-purpose stereotactic surgery system

NA - 07613252516927

ZEISS PENTERO MICROSKOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-075-000
In Commercial Distribution

  • 07613252516927 ()
7700-075-000

  • Multi-purpose stereotactic surgery system

HydroMark - 00841911101505

HydroMARK Breast Biopsy Site Marker
DEVICOR MEDICAL PRODUCTS, INC.
4010-03-09-T1
In Commercial Distribution

  • 10841911101502 ()
  • 00841911101505 ()

  • Needle Gauge: 9 Gauge


  • Radiological image marker, implantable

MMA (Methylmalonic Acid) Level 1 - B800740530

MMA (Methylmalonic Acid) Level 1
UTAK LABORATORIES, INC.
74053
In Commercial Distribution

  • B800740535 ()
  • B800740530 ()

  • Total Volume: 5 Milliliter
74053

  • Methylmalonic acid (MMA) IVD, control

Phosphate Buffered Saline/Citrate Reagent - 00814695020492

FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695020492 ()
PC1-500

  • Cell centrifugation/density gradient separation reagent IVD

Healgen - 00816490020950

14 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG /pH
Healgen Scientific Limited Liability Company
HCDOAV-1144A3
In Commercial Distribution

  • 20816490020954 ()
  • 10816490020957 ()
  • 00816490020950 ()
HCDOAV-1144A3

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

Healgen - 00816490020042

13 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-2135
In Commercial Distribution

  • 20816490020046 ()
  • 10816490020049 ()
  • 00816490020042 ()
HCDOAV-2135

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

Lympho-Kwik T Lymphocyte, 25 isolations - 00812117018799

Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018799 ()
LKT25

  • Cell centrifugation/density gradient separation reagent IVD

Lympho-Kwik T Lymphocyte, 50 isolations - 00812117018775

Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018775 ()
LK-50-T

  • Cell centrifugation/density gradient separation reagent IVD

Lambda Antigen Tray™ Class II - 00812117018713

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018713 ()
LATP240

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Single Antigen Class I - 00812117018706

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018706 ()
LATP1HD

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I - 00812117018690

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018690 ()
LATP140X2

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I - 00812117018683

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018683 ()
LATP140

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I & II - 00812117018676

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018676 ()
LATP1288

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I & II - 00812117018669

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018669 ()
LATP1240

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Mixed Class I & II - 00812117018652

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018652 ()
LATM20X5P

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Mixed Class I - 00812117018645

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018645 ()
LATM120P

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Mixed Class I & II - 00812117018638

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018638 ()
LATM10X5P

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Mixed Class I & II - Sample - 00812117018621

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018621 ()
LATM10SA

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Single Antigen Class I - Sample - 00812117018560

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018560 ()
LAT1HDS

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I - Sample - 00812117018553

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018553 ()
LAT140S

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I & II - Sample - 00812117018546

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018546 ()
LAT1288S

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I & II - Sample - 00812117018539

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018539 ()
LAT1240S

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I & II - 1 test - 00812117018522

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018522 ()
LAT124010

  • HLA class I & II antibody screening IVD, kit, multiplex

HLA Class I Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody - S - 00812117018478

These purified monoclonal antibodies are intended for in vitro diagnostic or research use in a qualitative, whole blood procedure for direct immunofluorescence staining of HLA-B27 or other lymphocyte surface antigens with analysis by flow cytometry.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018478 ()
HLAF50XSA

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

Mouse IgG2b Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody - S - 00812117018461

These purified monoclonal antibodies are intended for in vitro diagnostic or research use in a qualitative, whole blood procedure for direct immunofluorescence staining of HLA-B27 or other lymphocyte surface antigens with analysis by flow cytometry.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018461 ()
G2BFX-SAM

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 ml - 00812117018447

FluoroQuench products are used to fluorescently stain and fix lymphocytes in the microcytotoxicity assays.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018447 ()
FQZAE100

  • Microscope slide stainer IVD

Fluorobeads™ B Lymphocyte – 100 Isolations - 00812117018072

FluoroBeads-B provide a simple procedure for the isolation of B lymphocytes for use in HLA Class II typing assays using fluorescent dyes. PBS/Citrate is a reagent for use in the FluoroBeads-B isolation method.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018072 ()
FB2-100

  • Cell centrifugation/density gradient separation reagent IVD
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