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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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Unimed - 06945664802451

Reusable SpO2 Sensor/百特/Soft Tip/Adult/3.0M/045
Unimed Medical Supplies, Inc.
U410S-12
In Commercial Distribution

  • 06945664802451 ()


  • Pulse oximeter probe, reusable

Autostat II Anti-Thyroid Peroxidase - 00816879020045

96 well ELISA for the detection of anti-TPO antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA04
Not in Commercial Distribution

  • 00816879020045 ()


  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)

MicroTrak® - 05391516746144

MicroTrak® HSV-1/HSV-2 Direct Specimen Identification/Typing Test Control Slide Pack
TRINITY BIOTECH PUBLIC LIMITED COMPANY
8H399UL
Not in Commercial Distribution

  • 05391516746144 ()

  • 10 Slides
8H399UL

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control

Bartels® - 05391516745949

Bartels® Herpes Simplex Virus Antigen Control Slides
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-47B
Not in Commercial Distribution

  • 05391516745949 ()
  • 05391516748674 ()

  • 10 Slides
B1029-47B

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control

Bartels® - 05391516745925

Bartels® Anti-HSV mouse monoclonal FITC conjugate
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-47C
Not in Commercial Distribution

  • 05391516745925 ()

  • 50-100 Tests
B1029-47C

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, reagent

Bartels® - 05391516745864

Bartels® HSV Type 1 and Type 2 Antigen Control Slides
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-44C
Not in Commercial Distribution

  • 05391516745864 ()

  • 5 Sets
B1029-44C

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control

Poly Rb A-Herpes Simplex Virus Type 1 - 05700572001614

Polyclonal Rabbit Anti- Herpes Simplex Virus Type 1
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
B0114
In Commercial Distribution

  • 05700572001614 ()

  • Total Volume: 2 Milliliter


  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, antibody

Pathfinder - 00847865012768

Herpes Simplex Virus 1 and 2, 4 Well Slides
Bio-RAD Laboratories, Inc.
12000150
In Commercial Distribution

  • 00847865012768 ()

  • 5 Tests
  • 4 Wells
12000150

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, reagent

Pathfinder - 00847865001489

HSV Type 1 and 2, 2 Well Slides
Bio-RAD Laboratories, Inc.
30494
In Commercial Distribution

  • 00847865001489 ()

  • 2 Well
  • 90 Slides
30494

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, reagent

Pathfinder - 00847865001472

HSV Type 2 Monoclonal Antibody
Bio-RAD Laboratories, Inc.
30491
In Commercial Distribution

  • 00847865001472 ()

  • 100 Tests
  • Total Volume: 5 Milliliter
30491

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, reagent
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