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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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PathoCatch - 08908016644015

COVID-19 Antigen Fluorescence Immunoassay Kit
MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
MPF25
In Commercial Distribution

  • 08908016644015 ()
MPF25

  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

Genabio COVID-19 Rapid Self-Test Kit - 00196852953004

No Description
Genabio Diagnostics Inc.
RA9-E00302
In Commercial Distribution

  • 00196852953004 ()
  • 00196852254316 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

Genabio COVID-19 Rapid Self-Test Kit - 00196852928675

No Description
Genabio Diagnostics Inc.
RA9-E00305
In Commercial Distribution

  • 00196852254316 ()
  • 00196852928675 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

Genabio COVID-19 Rapid Self-Test Kit - 00196852254316

No Description
Genabio Diagnostics Inc.
RA9-E00301
In Commercial Distribution

  • 00196852254316 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

Genabio COVID-19 Rapid Self-Test Kit - 00196852195008

No Description
Genabio Diagnostics Inc.
RA9-E00325
In Commercial Distribution

  • 00196852254316 ()
  • 00196852195008 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid

Henry Schein - 00304040001516

Urispec + UA Reader
HENRY SCHEIN, INC.
9007566
In Commercial Distribution

  • 00304040001516 ()
9007566

  • Urine analyser IVD, laboratory, semi-automated

CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 - 00817302021387

ETHA (Alcohol) w/ cal - UDR CX/LX/DXC 2 x 150 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC421
Not in Commercial Distribution

  • 00817302021387 ()

  • Total Volume: 5 Milliliter
  • Total Volume: 32 Milliliter
  • Kit contains 2 Reagent cartridges, 1 Calibrator and 1 package insert
  • Total Volume: 11 Milliliter
CC421

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry

Ethanol Gen.2 - 07613336157817

No Description
Roche Diagnostics GmbH
08445672190
Not in Commercial Distribution

  • 07613336157817 ()
08445672190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry

Ethanol Gen.2 - 07613336121221

No Description
Roche Diagnostics GmbH
08057630190
In Commercial Distribution

  • 07613336121221 ()
08057630190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry

Ethyl Alcohol Enzymatic Assay - B07602210

Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
LIN-ZHI INTERNATIONAL, INC.
0221
In Commercial Distribution

  • B07602210 ()
0221

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
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