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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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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
RNA Process Control for Biomeme's SARS-CoV-2 assay form factors (Go-Strips, Go-Plate, or Bulk Vials)
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640076 ()
  • 00810096640079 ()
3000627

  • Exogenous DNA/RNA internal control IVD, kit
Void Filling Caps for sealing Biomeme PCR Go-Strips during thermocycling. Caps only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640069 ()
  • 00810096640062 ()
3000520

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640052 ()
  • 00810096640055 ()
3000633

  • Nucleic acid amplification mastermix reagent IVD
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
RNA Extraction Kit containing cartridges, syringes, and binding column tips.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640038 ()
  • 00810096640031 ()
3000536

  • Nucleic acid extraction/isolation kit IVD
Curaplex Opioid Overdose Kit (2 Dose, Face Shield, Yellow Case)
BOUND TREE MEDICAL, LLC
SRxOD2SY-24-KIT
In Commercial Distribution

  • 00810094576615 ()
SRxOD2SY-24-KIT

  • First aid kit, medicated
No Description
WatMIND USA
CARTON-1V500-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
In Commercial Distribution

  • 50810172700098 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
CARTON-2V300-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
In Commercial Distribution

  • 50810172700081 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
D C PACK
Cardinal Health 200, LLC
SMA11DCBV7
In Commercial Distribution

  • 50197106994267 ()
  • 10197106994269 ()
SMA11DCBV7

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
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