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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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Lyra - 30014613339144

SARS-CoV-2 Direct Assay
DIAGNOSTIC HYBRIDS, INC.
Coronavirus
In Commercial Distribution

  • 30014613339144 ()
M124

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Lyra - 30014613339090

Lyra SARS-CoV-2 Assay
DIAGNOSTIC HYBRIDS, INC.
Coronavirus
In Commercial Distribution

  • 30014613339090 ()
M120

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

RealTime - 00884999049109

Abbott RealTime SARS-CoV-2 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
09N77-095
In Commercial Distribution

  • 00884999049109 ()
09N77-095

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Alinity m - 00884999049222

Alinity m SARS-CoV-2 AMP Kit
ABBOTT MOLECULAR INC.
09N78-095
In Commercial Distribution

  • 00884999049222 ()
09N78-095

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Denture, restoration, splint - 06972677874182

No Description
Modern Dental Laboratory (DG) Co., Ltd.
418
In Commercial Distribution

  • 06972677874199 ()
  • 06972677874182 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Complete upper denture
  • Complete lower denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
  • Removable dental occlusal splint, preformed
  • Orthodontic retainer

Restoration - 06972677871440

No Description
Modern Dental Laboratory (DG) Co., Ltd.
144
In Commercial Distribution

  • 06972677871457 ()
  • 06972677871440 ()


  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
  • Dental casting non-noble alloy
  • Custom-made dental crown, metal

Restoration - 08936214221288

No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
128
In Commercial Distribution

  • 08936214221295 ()
  • 08936214221288 ()


  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
  • Dental casting non-noble alloy
  • Custom-made dental crown, metal

SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells - 00816870024875

No Description
MONOBIND, INC.
12525-300
In Commercial Distribution

  • 00816870024875 ()

  • Width: 7.75 Inch
12525-300B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 Wells - 00816870024868

No Description
MONOBIND, INC.
12525-300
In Commercial Distribution

  • 00816870024868 ()

  • Width: 7.75 Inch
12525-300A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SARS-CoV-2 IgM AccuBind ELISA Test System - 192 Wells - 00816870023649

No Description
MONOBIND, INC.
11725-300
In Commercial Distribution

  • 00816870023649 ()

  • Width: 7.75 Inch
11725-300B

  • SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
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