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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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MicroTrak® - 05391516746007

MicroTrak® HSV-1/HSV-2 Culture Identification/Typing Test
TRINITY BIOTECH PUBLIC LIMITED COMPANY
8H219UL
Not in Commercial Distribution

  • 05391516746007 ()

  • 18-85 Tests
8H219UL

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Bartels® - 05391516745932

Bartels® HSV Fluorescent Monoclonal Antibody Test
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-48
Not in Commercial Distribution

  • 05391516745932 ()

  • 100-200
B1029-48

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Bartels® - 05391516745918

Bartels® HSV Fluorescent Monoclonal Antibody Test
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-47
Not in Commercial Distribution

  • 05391516745918 ()

  • 50 - 100
B1029-47

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Bartels® - 05391516745826

Bartels® HSV Type Specific Fluorescent Monoclonal Antibody Test
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-44
Not in Commercial Distribution

  • 05391516745826 ()

  • 50 - 100 Tests
B1029-44

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Pathfinder - 00847865001465

Herpes Simplex Virus Types 1 and 2 Direct Antigen Detection System
Bio-RAD Laboratories, Inc.
25215
In Commercial Distribution

  • 00847865001465 ()

  • 50 Tests
25215

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Light Diagnostics HSV 1 Typing Reagent - 04053252678257

Light Diagnostics HSV 1 Typing Reagent
EMD Millipore Corporation
5233
Not in Commercial Distribution

  • 04053252678257 ()
5233

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Light Diagnostics HSV 2 Typing Reagent - 04053252670930

Light Diagnostics HSV 2 Typing Reagent
EMD Millipore Corporation
5234
Not in Commercial Distribution

  • 04053252670930 ()
5234

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Light Diagnostics SimulFluor HSV 1/HSV 2 Reagent - 04053252625213

Light Diagnostics SimulFluor HSV 1/HSV 2 Reagent
EMD Millipore Corporation
5243
Not in Commercial Distribution

  • 04053252625213 ()
5243

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Light Diagnostics™ HSV 1&2 Typing DFA Kit - 04053252620638

HSV 1 & 2 Typing DFA Kit
EMD Millipore Corporation
3291
Not in Commercial Distribution

  • 04053252620638 ()
3291

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

Light Diagnostics™ Simulfluor® HSV 1/ HSV 2 DFA Kit - 04053252589942

Simulfluor HSV 1/ HSV 2 DFA Kit
EMD Millipore Corporation
3293
Not in Commercial Distribution

  • 04053252589942 ()
3293

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay
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