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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90 Test Kit SARS-CoV-2 IgG Immunoassay
QUALIGEN INC.
SARS-CoV-2 IgG Immunoassay
In Commercial Distribution

  • 00816467020389 ()
  • 10816467020386 ()
25000085

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
No Description
Genabio Diagnostics Inc.
RA9-E00302
In Commercial Distribution

  • 00196852953004 ()
  • 00196852254316 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid
No Description
Genabio Diagnostics Inc.
RA9-E00305
In Commercial Distribution

  • 00196852254316 ()
  • 00196852928675 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid
No Description
Genabio Diagnostics Inc.
RA9-E00301
In Commercial Distribution

  • 00196852254316 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid
No Description
Genabio Diagnostics Inc.
RA9-E00325
In Commercial Distribution

  • 00196852254316 ()
  • 00196852195008 ()


  • SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid
D & C PACK
AMERICAN CONTRACT SYSTEMS, INC.
TNDC88F
In Commercial Distribution

  • 00191072185464 ()


  • General surgical procedure kit, non-medicated, single-use
D & C PACK
AMERICAN CONTRACT SYSTEMS, INC.
BLDC35F
In Commercial Distribution

  • 00191072178640 ()


  • General surgical procedure kit, non-medicated, single-use
D & C PACK
AMERICAN CONTRACT SYSTEMS, INC.
LLDC40J
In Commercial Distribution

  • 00191072177421 ()


  • General surgical procedure kit, non-medicated, single-use
D AND E
AMERICAN CONTRACT SYSTEMS, INC.
MEDE10Q
In Commercial Distribution

  • 00191072174406 ()


  • General surgical procedure kit, non-medicated, single-use
D AND C LF SJW
AMERICAN CONTRACT SYSTEMS, INC.
SWDC44F
In Commercial Distribution

  • 00191072167743 ()


  • General surgical procedure kit, non-medicated, single-use
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