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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Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
0160
In Commercial Distribution

  • B07601600 ()
0160

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0101
In Commercial Distribution

  • B07601010 ()
0101

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
0100
In Commercial Distribution

  • B07601000 ()
0100

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0041
In Commercial Distribution

  • B07600410 ()
0041

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
Small Test Kit. Antibody/Substrate Reagent (R1): 100 mL. Enzyme Conjugate Reagent (R2): 37.5 mL.
LIN-ZHI INTERNATIONAL, INC.
0040
In Commercial Distribution

  • B07600400 ()
0040

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
RG-M7593-D
Not in Commercial Distribution

  • B110RGM7593D0 ()
RG-M7593-D

  • Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)
Adjustable Torque Wrench (for BioHorizons)
ALTATEC GmbH
BIOTORQ
In Commercial Distribution

  • E219BIOTORQ1 ()
  • E219BZ53201030300 ()
BZ5320.1030

  • Dental torque wrench
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-Max15
In Commercial Distribution

  • B510PMMAX15 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-Max13
In Commercial Distribution

  • B510PMMAX13 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000XL PRO
In Commercial Distribution

  • B510PM2000XLPRO1 ()


  • Multiple vital physiological parameter monitoring system, clinical
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