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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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One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006002 ()

  • Height: 1.75 Inch
  • Width: 4.0 Inch
  • Length: 9.25 Inch
HHECT01

  • Cricothyrotomy kit, single-use
The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.
TECHLAB, INC.
T5032
Not in Commercial Distribution

  • 00857031002547 ()


  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.
TECHLAB, INC.
T30408
In Commercial Distribution

  • 00857031002400 ()


  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.
TECHLAB, INC.
T5031
In Commercial Distribution

  • 00857031002240 ()


  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.
TECHLAB, INC.
T30407
In Commercial Distribution

  • 00857031002165 ()


  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.
TECHLAB, INC.
30401
In Commercial Distribution

  • 00857031002127 ()


  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
Zacurate Combined Pregnancy Kit - 60 Ovulation strip + 20 Pregnancy strips
EINSTEIN ASSOCIATES LLC
M490N-CBAA-EGZA
In Commercial Distribution

  • 00856964007322 ()
M490N-CBAA-EGZA

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
80mm x 16 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG8016-RF
In Commercial Distribution

  • 00856895008658 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode
68.5mm x 16 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG6916-RF
In Commercial Distribution

  • 00856895008641 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode
61.5mm x 16 Contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG6216-RF
In Commercial Distribution

  • 00856895008634 ()


  • Percutaneous radio-frequency ablation probe, brain-ablation
  • Depth electrode
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