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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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No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0425
In Commercial Distribution

  • 04049016145660 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0225
In Commercial Distribution

  • 04049016145653 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0125
In Commercial Distribution

  • 04049016145646 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity s Concentrated Wash Buffer
Abbott Ireland Diagnostics
06P1388
In Commercial Distribution

  • 00380740118181 ()
06P1388

  • Buffered wash solution IVD
App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Biomeme, Inc.
2.3.5
In Commercial Distribution

  • 00810096640130 ()


  • 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
In Commercial Distribution

  • 10810096640106 ()
  • 00810096640109 ()
3000577

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
EUA
INBIOS INTERNATIONAL, INC
COV2-E
In Commercial Distribution

  • B379COV2E0 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199976
In Commercial Distribution

  • 10758750034581 ()
6199976

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
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