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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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NeuMoDx SARS-CoV-2 Test Strip - 10814278021264

No Description
Neumodx Molecular, Inc.
300800
In Commercial Distribution

  • 00814278021267 ()
  • 10814278021264 ()
300800

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

Vista COV2T Assay - 00630414605500

Vista COV2T Assay
Siemens Healthcare Diagnostics Inc.
11417414
Not in Commercial Distribution

  • 00630414297613 ()
  • 00630414605500 ()
K7414

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

Dimension CV2T Assay - 00630414605418

Dimension CV2T Assay
Siemens Healthcare Diagnostics Inc.
11417412
Not in Commercial Distribution

  • 00630414297590 ()
  • 00630414605418 ()
RF812

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

EURORealTime SARS-CoV-2 - 04049016145745

No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0200
In Commercial Distribution

  • 04049016145745 ()


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

EURORealTime SARS-CoV-2 - 04049016145691

No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0100
In Commercial Distribution

  • 04049016145691 ()


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

EURORealTime SARS-CoV-2 - 04049016145660

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

  • 04049016145660 ()


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

EURORealTime SARS-CoV-2 - 04049016145653

No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0225
In Commercial Distribution

  • 04049016145653 ()


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

EURORealTime SARS-CoV-2 - 04049016145646

No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0125
In Commercial Distribution

  • 04049016145646 ()


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

VITROS - 10758750034581

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

VITROS - 10758750034567

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199975
In Commercial Distribution

  • 10758750034567 ()
6199975

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