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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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DIAZO-CHEK - 00860009154018

The DIAZO-CHEK test is used to qualitatively detect bilirubin in urine or confirm the positive results obtained by a reagent strip. The Test is intended for use by the appropriately trained laboratory professionals. The test consists of Reagent discs and the test pads which bind the bilirubin from a Urine specimen. The test is based on the diazo coupling reaction between the adsorbed bilirubin and a stabilized diazonium salt of Nitrobenzene. The reaction results in the development of varying grades of purple to bluish-purple color which is easily visible by the naked eye.
Biorex Labs LLC
1
In Commercial Distribution

  • 00860009154018 ()
B1009

  • Urine bilirubin IVD, kit, rapid colorimetric, clinical

Maeves Pads, Maeves - 00860008137050

Sanitary Pads, Overnight, retail, 8ct
Maevespads LLC
MAEVES-360
In Commercial Distribution

  • 10860008137026 ()
  • 00860008137050 ()
  • 00860008137067 ()


  • Menstrual pad, unscented

CVS Health At Home - 00860008357847

Dry blood spot card collection kit utilizing 903 Five Spot Blood Card and Hologic Aptima Urine transport tube.
Blackfly Investments, LLC
STI collection kit
In Commercial Distribution

  • 00860008357847 ()
50428654200

  • Dried blood spot collection kit IVD
  • Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
  • Blood collection paper

Maeves Pads, Maeves - 00860008137043

Sanitary Pads, Overnight, retail, 10ct
Maevespads LLC
MAEVES-290
In Commercial Distribution

  • 10860008137019 ()
  • 00860008137043 ()
  • 00860008137074 ()


  • Menstrual pad, unscented

Maeves Pads, Maeves - 00860008137036

Sanitary Pads, Overnight, retail, 12ct
Maevespads LLC
MAEVES-245
In Commercial Distribution

  • 20860008137009 ()
  • 00860008137036 ()
  • 00860008137081 ()


  • Menstrual pad, unscented

UroMap Specimen Collection Kit - 00860193001761

The UroMap Specimen Collection Kit is intended for the collection and processing of urine specimens for the assessment of the probability of T-cell mediated rejection and BK virus nephropathy in kidney transplant patients. The UroMap Specimen collection kit is not intended for home use and is intended to be used by trained medical personnel.
CAREDX, INC.
UM-00001
In Commercial Distribution

  • 00860193001761 ()
UM-00001

  • Urine specimen collection kit IVD

KidneyCare Specimen Collection Kit - 00860193001747

Convenience mobile phlebotomy sample collection kit
CAREDX, INC.
AS-00005
In Commercial Distribution

  • 00860193001747 ()
AS-00005

  • Phlebotomy kit

KidneyCare Specimen Collection Kit - 00860193001730

Convenience Kit for Specimen Collection Phlebotomy
CAREDX, INC.
AS-00004
In Commercial Distribution

  • 00860193001730 ()
AS-00004

  • Phlebotomy kit

HeartCare Specimen Collection Kit - 00860193001723

Convenience Kit for Phlebotomy of blood sample for HeartCare testing
CAREDX, INC.
HTx-00009
In Commercial Distribution

  • 00860193001723 ()
HTx-00009

  • Phlebotomy kit

Allomap Specimen Collection Kit - 00860193001716

Convenience Kit for Phlebotomy of blood sample for AlloMap testing
CAREDX, INC.
HTx-00007
In Commercial Distribution

  • 00860193001716 ()


  • Phlebotomy kit
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