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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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Restoration - 06972677871204

No Description
Modern Dental Laboratory (DG) Co., Ltd.
120
In Commercial Distribution

  • 06972677871211 ()
  • 06972677871204 ()


  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic

Sofia - 30014613339229

Sofia®2 Flu + SARS Antigen FIA
QUIDEL CORPORATION
20377
In Commercial Distribution

  • 30014613339229 ()
20377

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

CARDINAL HEALTH - 10197106688373

KIT, NEW ANESTHESIA
Cardinal Health 200, LLC
ANE548812A
In Commercial Distribution

  • 50197106688371 ()
  • 10197106688373 ()
ANE548812A

  • Peripheral anaesthesia single-administration set, non-medicated

CARDINAL HEALTH - 10195594897819

PAIN TRAY
Cardinal Health 200, LLC
34-8308C
In Commercial Distribution

  • 50195594897817 ()
  • 10195594897819 ()
34-8308C

  • Peripheral anaesthesia single-administration set, non-medicated

CARDINAL HEALTH - 10195594701390

KIT, PEDIATRIC ANESTHESIA
Cardinal Health 200, LLC
ANE7323591
In Commercial Distribution

  • 50195594701398 ()
  • 10195594701390 ()
ANE7323591

  • Peripheral anaesthesia single-administration set, non-medicated

Alinity m - 00884999049406

Alinity m Resp-4-Plex CTRL Kit
ABBOTT MOLECULAR INC.
09N79-086
In Commercial Distribution

  • 00884999049406 ()
09N79-086

  • Multiple-genus respiratory virus nucleic acid IVD, control

OSOM Flu SARS-CoV-2 Combo Control Kit - 00742860000072

OSOM Flu SARS-CoV-2 Combo Control Kit
SEKISUI DIAGNOSTICS, LLC
1079
In Commercial Distribution

  • 00742860000072 ()
  • 50742860100678 ()
  • 10742860000079 ()


  • Multiple-genus respiratory virus antigen IVD, control

Biomeme SARS-CoV-2 Go-Plates Kit - 00810096640086

Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640083 ()
  • 00810096640086 ()
3000562

  • Nucleic acid amplification mastermix kit IVD

Biomeme SARS-CoV-2 Go-Strips Kit - 00810096640048

Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit and Void Filling Caps.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640045 ()
  • 00810096640048 ()
3000555

  • Nucleic acid amplification mastermix kit IVD

BioFire® Respiratory Panel 2.1 EUA - 00815381020482

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423738
Not in Commercial Distribution

  • 00815381020482 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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