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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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Chembio DPP HIV 1/2 Assay - 00607158000007

The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
65-9500-0
In Commercial Distribution

  • 00607158000007 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

OraQuick In Home HIV Test - 00608337103403

No Description
Orasure Technologies, Inc.
1001-0340
In Commercial Distribution

  • 10608337103400 ()
  • 00608337103403 ()
  • 00608337000948 ()
  • 20608337103407 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

OraQuick In Home HIV Test, Pharmacy - 00608337001334

No Description
Orasure Technologies, Inc.
1001-0528
In Commercial Distribution

  • 10608337001331 ()
  • 00608337001334 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

OraQuick In Home HIV Test (Not for Resale) - 00608337000962

No Description
Orasure Technologies, Inc.
1001-0374
In Commercial Distribution

  • 10608337000969 ()
  • 00608337000962 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

OraQuick Advance Rapid HIV 1/2 Antibody Test - 00608337000016

No Description
Orasure Technologies, Inc.
3001-1197
In Commercial Distribution

  • 20608337000010 ()
  • 00608337000016 ()
  • 10608337000013 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

meijer - 00713733229203

Extreme Hydrocolloid blister cushion, all one size, 42 mm x 68 mm
MEIJER, INC.
713733229203
In Commercial Distribution

  • 10713733229200 ()
  • 00713733229203 ()
  • 60713733229205 ()
4300495

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

Meijer - 00713733086141

Wart Freezer Cryogenic Treatment 1-Step Wart Remover
MEIJER, INC.
4080389
In Commercial Distribution

  • 10713733086148 ()
  • 00713733086141 ()

  • Height: 155 Millimeter
4080389

  • Wart-removal cryogenic kit

INSTI HIV-1/HIV-2 Control Test - 06865979010313

INSTI HIV-1/HIV-2 Control Test
Biolytical Laboratories Inc
90-1031
Not in Commercial Distribution

  • 06865979010313 ()
90-1031

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

HIV-1 Control Test Kit - 06865979010306

HIV-1 Control Test Kit
Biolytical Laboratories Inc
90-1030
Not in Commercial Distribution

  • 06865979010306 ()
90-1030

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Healthy Accents - 00725439992763

Wart Freezer 1-step wart remover
FOOD LION, LLC
355850
Not in Commercial Distribution

  • 10725439992760 ()
  • 00725439992763 ()

  • Height: 155 Millimeter
355850

  • Wart-removal cryogenic kit
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