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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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EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0100
In Commercial Distribution

  • 04049016145691 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
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)
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)
Solana SARS-CoV-2 Assay
DIAGNOSTIC HYBRIDS, INC.
Coronavirus
In Commercial Distribution

  • 30014613339656 ()
M313

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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 SARS-CoV-2 Assay
DIAGNOSTIC HYBRIDS, INC.
Coronavirus
In Commercial Distribution

  • 30014613339090 ()
M120

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