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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Neptune 2x2 hemostatic pad
Tz Medical, Inc.
8870-01
In Commercial Distribution

  • 00811331010008 ()
  • 00811331010473 ()


  • Wound compression dressing
Pointe Phencyclidine (PCP) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-PH0020-1L
In Commercial Distribution

  • 00811727016461 ()
60-PH0020-1L

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Pointe Phencyclidine (PCP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-PH0020-100
In Commercial Distribution

  • 00811727016454 ()
60-PH0020-100

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Avalon Biomed NeoSolv - 8 oz Bottle
NUSMILE, LTD.
ABNS8
In Commercial Distribution

  • 00810118106422 ()


  • Root canal cleaning solution
Avalon Biomed NeoSolv - 4 oz Bottle
NUSMILE, LTD.
ABNS4
In Commercial Distribution

  • 00810118106415 ()


  • Root canal cleaning solution
For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO TYPING TESTS and LABType XR and CWD DNA Typing Test assays.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015484 ()
LSPSAB2

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014654 ()
LS2AEX01

  • HLA class I & II antibody screening IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010199 ()
LS1AEX01

  • HLA class I & II antibody screening IVD, kit, multiplex
ARK™ Methotrexate II Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0004-00
In Commercial Distribution

  • 00812101031223 ()
5071-0004-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-02
In Commercial Distribution

  • 00812101031216 ()
5071-0003-02

  • Methotrexate therapeutic drug monitoring IVD, control
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