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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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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

FluoroBeads™ T Developer (10X) - 00812117018058

FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescent dyes. FluoroBeads-T Developer is specifically designed to be used in the FluoroBeads-T isolation method.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018058 ()
FB1-DEV

  • Cell centrifugation/density gradient separation reagent IVD

Fluorobeads™ T Lymphocyte – 100 Isolations - 00812117018041

FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescent dyes. FluoroBeads-T Developer is specifically designed to be used in the FluoroBeads-T isolation method.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018041 ()
FB1-100

  • Cell centrifugation/density gradient separation reagent IVD

Terasaki HLA-B27 Dry Tissue Typing Tray - 6-test tray - 00812117016900

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
n/a
In Commercial Distribution

  • 00812117016900 ()
27-06D

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

FluoroQuench Acridine Orange/Ethidium Bromide - 2000 ml - 00812117016207

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

  • 00812117016207 ()
FQAE2000

  • Microscope slide stainer IVD

FluoroQuench Acridine Orange/Ethidium Bromide - 500ml - 00812117016184

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

  • 00812117016184 ()
FQAE500

  • Microscope slide stainer IVD

FluoroQuench Acridine Orange/Ethidium Bromide - 100ml - 00812117015897

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

  • 00812117015897 ()
FQAE100

  • Microscope slide stainer IVD

Fluorobeads™ B Lymphocyte – 25 Isolations - 00812117015880

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

  • 00812117015880 ()
FB2-25

  • Cell centrifugation/density gradient separation reagent IVD

Fluorobeads™ T Lymphocyte – 25 Isolations - 00812117015873

FluoroBeads-T provide a simple procedure for the isolation of T lymphocytes for use in microcytotoxicity assays using fluorescent dyes. FluoroBeads-T Developer is specifically designed to be used in the FluoroBeads-T isolation method.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015873 ()
FB1-25

  • Cell centrifugation/density gradient separation reagent IVD

Mouse IgG2b Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody - 00812117015569

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

  • 00812117015569 ()
G2BF50X

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

HLA-B27 Fluorescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody - 00812117015552

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

  • 00812117015552 ()
B27F50X

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

Simultag™ HLA-B27 Fluorescein Isothiocyanate / CD3 R-Phycoerythrin Monoclonal An - 00812117015545

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

  • 00812117015545 ()
27FC3P50

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

HLA Class I Fluroescein Isothiocyanate (FITC) Conjugated Monoclonal Antibody - 00812117015538

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

  • 00812117015538 ()
HLA1F50X

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

Terasaki HLA Class II Dry Tissue Typing Tray - 00812117015279

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015279 ()
DR72D

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

Lyophilized Class II Complement - 00812117014357

Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014357 ()
CDR-1D

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

Lyophilized Class I Complement - 00812117014340

Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014340 ()
CABC-1D

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

Lambda Antigen Tray™ Single Antigen Class I - 00812117012537

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

  • 00812117012537 ()
LAT1HD

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

Lambda Antigen Tray™ - Mixed Class I & II - 00812117012520

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

  • 00812117012520 ()
LATM20X5

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

Lambda Antigen Tray™ - Mixed Class I & II - 00812117012513

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

  • 00812117012513 ()
LATM10X5

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

Lambda Antigen Tray™ - Mixed Class I - 00812117012506

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

  • 00812117012506 ()
LATM120

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

Lambda Antigen Tray™ Class I & II - 00812117012490

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

  • 00812117012490 ()
LAT1288

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

Lambda Antigen Tray™ Class I & II - 2 test tray - 00812117012483

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

  • 00812117012483 ()
LAT1240

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

Lambda Antigen Tray™ Class II - 2 test tray - 00812117012476

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

  • 00812117012476 ()
LAT240

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

Lambda Antigen Tray™ Class I - 2 test tray - 00812117012469

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

  • 00812117012469 ()
LAT140X2

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

Lambda Antigen Tray™ Class I - 1 test tray - 00812117012452

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

  • 00812117012452 ()
LAT140

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

Terasaki HLA Class I Asian Dry Tissue Typing Tray - 00812117010175

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010175 ()
ASN72D

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

Terasaki HLA Class I Dry Tissue Typing Tray - 00812117010168

For use in determining HLA Class I and Class II cell surface antigens with a complement dependent microlymphocytotoxic technique.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010168 ()
AB72D

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

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

INVADER - 15420045506725

No Description
Hologic, Inc.
INVADER MTHFR 1298, 1680 TESTS
Not in Commercial Distribution

  • 15420045506725 ()
95-459

  • Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)
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