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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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A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601684
In Commercial Distribution

  • 00690286000780 ()
  • 10690286000787 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Phencyclidine, Cocaine, Methamphetamine (MAMP), Opiates, Amphetamine, Benzodiazepines, Tricyclic Antidepressants, Methadone, Barbiturates, Oxycodone, Propoxyphene, and Buprenorphine drugs and/or metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
604022
In Commercial Distribution

  • 00690286000049 ()
  • 10690286000046 ()


  • Multiplex analyser IVD, laboratory
  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens
Luminex Molecular Diagnostics, Inc
I006C0068
Not in Commercial Distribution

  • 00840487100455 ()
I006C0068

  • Cystic fibrosis IVD, kit, multiplex
ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Circumferentially Offset Sleeves, Size 2XL
STANDARD TEXTILE CO., INC.
75615073
In Commercial Distribution

  • 10634916819042 ()
  • 00634916819045 ()


  • Surgical gown, reusable
Blue Diamond® Patient Restraint Strap, extra long, is traditional rubber patient restraint with 2 airplane style buckles. It has a large mid panel that is protected by a removable Blue Diamond gel pad.
David Scott Company
BD2620XL
In Commercial Distribution

  • 15060797552139 ()

  • Width: 5 Inch
  • Length: 132 Inch
  • Height: .375 Inch
BD2620XL

  • Operating table patient pressure distribution pad, reusable
Control Swabs intended for use only with the ID NOW Influenza A & B product.
Alere Scarborough, Inc.
425-080
Not in Commercial Distribution

  • 10811877010439 ()


  • Influenza A/B virus nucleic acid IVD, control
No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021874 ()

  • Width: 7.75 Inch
7025-300E

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021850 ()

  • Width: 7.75 Inch
7025-300B

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7025-300
In Commercial Distribution

  • 00816870021867 ()

  • Width: 7.75 Inch
7025-300D

  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
7075-300
In Commercial Distribution

  • 00816870023311 ()

  • Width: 7.75 Inch
7075-300E

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
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