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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For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.300
In Commercial Distribution

  • 15051716000305 ()
TB.300US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of M.Tuberculosis infection in conjunction with risk assessment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.50
In Commercial Distribution

  • 15051716000046 ()
TB.50US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Oxford Immunotec, Inc.
TB.200
In Commercial Distribution

  • 15051716000008 ()
TB.200US

  • Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatment objective . The optical system focuses the laser beam into the corneal tissue. The VisuMax femtosecond laser is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments: - In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea - In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty - In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting - Surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. Additionally under class III: The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism • for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters, • for cylinder from -0.75 diopters through -3.00 diopters, • when refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
Carl Zeiss Meditec AG
VisuMax
In Commercial Distribution

  • 04049471095036 ()

  • Weight (basic unit) 470 kg
  • Weight (PSS): 250 kg
  • Weight (platform): 150 kg
  • L x W: 4.00 m x 3.70 m


  • Femtosecond ophthalmic solid-state laser system
Alinity i Anti-HBc IgM Controls
Abbott GmbH
07P8612
In Commercial Distribution

  • 00380740145187 ()
07P8612

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
ARCHITECT CORE-M Controls
Abbott GmbH
6L23-10
In Commercial Distribution

  • 00380740011147 ()
06L2310

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
HBc IgM (aHBcM) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10308979
In Commercial Distribution

  • 00630414470504 ()
504945

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
HBc IgM (aHBcM) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995450
In Commercial Distribution

  • 00630414597805 ()
10995450

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Anti-HBc IgM EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26201
In Commercial Distribution

  • 00847865013154 ()

  • Total Volume: 0.8 Milliliter
26201

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Anti-HBc IgM EIA, Positive Control,1.6 mL
Bio-RAD Laboratories, Inc.
26200
In Commercial Distribution

  • 00847865013147 ()

  • Total Volume: 1.6 Milliliter
26200

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
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