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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No Description
Yiwu Ori-Power Medtech Co.,Ltd.
OP3000125
In Commercial Distribution

  • 06974686052148 ()
  • 06974686057273 ()


  • First aid kit, medicated
No Description
Yiwu Ori-Power Medtech Co.,Ltd.
OP3000395
In Commercial Distribution

  • 06974686056511 ()
  • 06974686052148 ()


  • First aid kit, medicated
No Description
Neumodx Molecular, Inc.
300800
Not in Commercial Distribution

  • 00814278021267 ()
  • 10814278021264 ()
300800

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Tubes filled with 3mL aliquots of Biomemes DNA/RNA Preservation buffer for sample collection, storage, and preservation at room temperature. Pack of 100 pre-filled tubes.
Biomeme, Inc.
1
Not in Commercial Distribution

  • 10810096640106 ()
  • 00810096640109 ()
3000577

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
Not in Commercial Distribution

  • 10810096640090 ()
  • 00810096640093 ()
3000634

  • Nucleic acid amplification mastermix reagent IVD
Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit.
Biomeme, Inc.
1
Not 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
Not 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
Not 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
Not 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
Not in Commercial Distribution

  • 10810096640045 ()
  • 00810096640048 ()
3000555

  • Nucleic acid amplification mastermix kit IVD
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