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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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The Maxim HIV-1 Urine Enzyme Immunoassay is an enzyme immunoassay for the in vitro detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in urine. The test is intended for use in professional laboratory settings as an aid in clinical diagnosis of HIV infection. Before a determination of HIV-1 status can be made, specimens that are repeatedly reactive using this test should be further tested only using the additional, more specific, Cambridge Biotech HIV-1 Urine Western Blot test.
BLUEJAY DIAGNOSTICS, INC.
01
In Commercial Distribution

  • 00864525000415 ()
40000

  • HIV1 antibody IVD, kit, enzyme immunoassay (EIA)
Allereye® is a rapid immunoassay for the detection of total IgE in tears.
BLUEJAY DIAGNOSTICS, INC.
01
In Commercial Distribution

  • 00864525000408 ()
380003G

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
The cuvette strips are manufactured especially for Atellica® DT 250 Analyzer and are intended to use for performing tests only on those instruments.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Atellica DT Cuvettes (280pcs)
In Commercial Distribution

  • 05999883586907 ()
11310512

  • Laboratory analyser cuvette IVD, reusable
The Atellica® DT 250 analyzer is a fully automated wet-chemistry analyzer for in vitro diagnostic use. The analyzer is used to measure a variety of analytes by photometric principle in human samples, in a quantitative way, with reagents that may be adaptable. The Atellica® DT 250 Analyzer menu is focused on Drugs of Abuse Testing assays (DAT), Therapeutic Drug Monitoring (TDM) assays, and Immunosuppressant Drug (ISD) assays.
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Atellica DT 250
In Commercial Distribution

  • 15999883586744 ()
  • 05999883586747 ()

  • Height: 660 Millimeter
  • Depth: 700 Millimeter
  • Width: 880 Millimeter
11310504

  • Multiple clinical chemistry analyser IVD, laboratory
No Description
Brainlab AG
20100131
Not in Commercial Distribution

  • 04260583190017 ()


  • Robotic surgical navigation system
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
IPL3500
In Commercial Distribution

  • 00074590550863 ()
  • 10074590550860 ()
  • 20074590550867 ()
0074590550863

  • Cosmetic red-light phototherapy system, home-use
The MetaFlex Glove combines targeted compression to enhance circulation with innovative resistance bands. This powerful combination may reduce pain while improving hand mobility and strength, promoting the functional use of your hands.
ATS Innovations
13437
In Commercial Distribution

  • D481454 ()
  • G342134370 ()


  • Compression/pressure glove
  • Finger/hand exerciser
Chisels cvd. 13cm 4mm vienna model
A. Schweickhardt GmbH & Co. KG
926-4
In Commercial Distribution

  • E89692640 ()
926-4

  • Dental elevator, tooth/root
Chisels cvd. 13cm 3mm vienna model
A. Schweickhardt GmbH & Co. KG
926-3
In Commercial Distribution

  • E89692630 ()
926-3

  • Dental elevator, tooth/root
Chisels cvd. 13cm 2mm vienna model
A. Schweickhardt GmbH & Co. KG
926-2
In Commercial Distribution

  • E89692620 ()
926-2

  • Dental elevator, tooth/root
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