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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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Healqu - 00819143021373

Healqu Hydrocolloid Extra Thin Dressing 6x6
Healqu LLC
9024266
In Commercial Distribution

  • 10819143021370 ()
  • 00819143021373 ()
  • 20819143021377 ()
  • 00819143025326 ()
  • 00819143025333 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

MobiLab Standard Sexual Health Self Rapid Test - 00860008737304

The MobiLab Standard Sexual Health Self Screening Kit (urine specimen) includes individual test cassettes for: 1. Trichomonas Vaginalis (TV) 2. Candida Albicans (Yeast) (CA) 3. Gardnerella Vaginalis (GV) 4. Mycoplasma Genitalium (MG) 5. Chlamydia Trachomatis (CHT) 6. Neisseria Gonorrhoeae (NGH). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.
MobiLab Medical Innovatives Inc.
MSSH
Not in Commercial Distribution

  • 00860008737304 ()


  • Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use

BioButton Rechargeable Adhesives - 00850005949237

Adhesive accessory packs for wearable devices (OMI, ADB); ACCS-1-ST06-1-4
BIOINTELLISENSE, INC.
ACCS-1-ST06-1-4
In Commercial Distribution

  • 10850005949234 ()
  • 00850005949237 ()
  • 30850005949238 ()
  • 20850005949231 ()
  • 40850005949235 ()
N/A

  • Dressing-fixation skin adhesive tape, non-silicone

Healqu - 00819143020888

Healqu Transparent Dressing (23/8 x 23/4)
Healqu LLC
9020901
In Commercial Distribution

  • 30819143020889 ()
  • 00819143020888 ()
  • 20819143020882 ()
  • 00819143024114 ()
  • 00819143024121 ()
  • 00819143025203 ()
  • 00819143025210 ()
  • 00819143025302 ()
  • 00819143025319 ()


  • Synthetic polymer semi-permeable film dressing, adhesive
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