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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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Human Keratin Matrix
Progenacare Global, LLC
PM3004
In Commercial Distribution

  • 00850017159044 ()

  • Length: 4 Centimeter
  • Width: 4 Centimeter


  • Collagen wound matrix dressing
Human Keratin Matrix
Progenacare Global, LLC
PM3003
In Commercial Distribution

  • 00850017159013 ()

  • Length: 3 Centimeter
  • Width: 3 Centimeter


  • Collagen wound matrix dressing
TOX/See Drug Screen Test PCP
BIO-RAD LABORATORIES, INC.
194-5194
In Commercial Distribution

  • 00847817000683 ()
1945194

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
The ARK Methotrexate Assay c-Pack is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-02
In Commercial Distribution

  • 00858724003254 ()
5026-0001-02

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK Methotrexate Assay (non c-Pack format) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-01
In Commercial Distribution

  • 00858724003216 ()
5026-0001-01

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-00
In Commercial Distribution

  • 00858724003056 ()
5026-0001-00

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
AccuSign® PCP card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-205-10-02
In Commercial Distribution

  • 10743816000136 ()
DOA-205-10-02

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
AccuSign® PCP card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-205-35-02
In Commercial Distribution

  • 10743816000129 ()
DOA-205-35-02

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
VITROS Chemistry Products PCP Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801998
In Commercial Distribution

  • 10758750001842 ()
  • 20758750001849 ()
6801998

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
PCP (Phencyclidine) 3 x 375 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
ST414
In Commercial Distribution

  • 00817302021639 ()

  • Total Volume: 63 Milliliter
  • Total Volume: 26 Milliliter
  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
ST414

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
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