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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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AccuDiag ™ - 00894175000008

AccuDiag ™ IFA FTA-ABS Test System - Treponema pallidum total antibody IVD, kit, Fluorescent Immunoassay Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
Diagnostic Automation, Inc.
DACD-351010
In Commercial Distribution

  • 00894175000008 ()

  • 10x10 wells
351010

  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

Oratect Oral Fluid Collection Tube - 00816555020208

Oral Fluid Specimen Collection Tube
BRANAN MEDICAL CORPORATION
CM-190
Not in Commercial Distribution

  • 00816555020208 ()
CM-190

  • Drug-testing specimen collection kit IVD

Oratect Oral Fluid Collection Tube - 00816565020847

Oral Fluid Specimen Collection Tube
AMEDITECH INC.
CM-190
Not in Commercial Distribution

  • 00816565020847 ()
CM-190

  • Drug-testing specimen collection kit IVD

DiamondTemp™ Irrigation Pump - 00763000709051

IRRIGATION PUMP CEDTP100 US
MEDTRONIC, INC.
CEDTP100
In Commercial Distribution

  • 00763000709051 ()


  • Basic roller pump

DiamondTemp™ FASTR RF Generator - 00763000708917

GENERATOR CEDTG200 FASTR RF US
MEDTRONIC, INC.
CEDTG200
In Commercial Distribution

  • 00763000708917 ()


  • Cardiac radio-frequency ablation system generator

DiamondTemp™ FASTR RF Generator - 00763000687960

GENERATOR CEDTG200 FASTR RF US/CAN
MEDTRONIC, INC.
CEDTG200
In Commercial Distribution

  • 00763000687960 ()


  • Cardiac radio-frequency ablation system generator

DiamondTemp™ Irrigation Pump - 00763000540616

IRRIGATION PUMP CEDTP100 US/CAN
MEDTRONIC, INC.
CEDTP100
In Commercial Distribution

  • 00763000540616 ()


  • Basic roller pump

NA - 20613994697268

CRTG 304-11POR PORC HMS BLK 5L INT 9PK
MEDTRONIC, INC.
304-11POR
In Commercial Distribution

  • 20613994697268 ()
  • 00613994697264 ()

  • Range: 3.5-6.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic

NA - 20613994697251

CRTG 304-10POR PORC HMS PRP 5L INT 9PK
MEDTRONIC, INC.
304-10POR
In Commercial Distribution

  • 20613994697251 ()
  • 00613994697257 ()

  • Range: 4.5-6.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic

NA - 20613994697244

CRTG 304-09POR PORC HMS WHT 5L INT 9PK
MEDTRONIC, INC.
304-09POR
In Commercial Distribution

  • 20613994697244 ()
  • 00613994697240 ()

  • Range: 2.5-5.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
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