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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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ARCHITECT - 00380740191832

SARS-CoV-2 IgG Reagent Kit 100 Tests
ABBOTT LABORATORIES
06R8620
In Commercial Distribution

  • 00380740191832 ()
06R8620

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

AEMT KIT - M6898811201010

AEMT KIT SWAT-T Tourniquet 1 ea Celox Rapid 1 ea Duct Tape 1 ea
Safeguard US Operating, LLC
04
In Commercial Distribution

  • M6898811201010 ()
88-112-01

  • First aid kit, non-medicated, single-use

Vista COV2G Assay - 00630414607139

Vista COV2G Assay
Siemens Healthcare Diagnostics Inc.
11417771
Not in Commercial Distribution

  • 00630414298382 ()
  • 00630414607139 ()
K7771

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Dimension CV2GAssay - 00630414607030

Dimension CV2G Assay
Siemens Healthcare Diagnostics Inc.
11417770
Not in Commercial Distribution

  • 00630414298375 ()
  • 00630414607030 ()
RF870

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

SARS-CoV-2 IgG ELISA Kit - 05700571113011

SARS-CoV-2 IgG ELISA Kit
AGILENT TECHNOLOGIES, INC.
K1919
In Commercial Distribution

  • 05700571113011 ()

  • 180 tests


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-SARS-CoV-2 ELISA (IgG) - 04049016145554

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2606-9601 G
In Commercial Distribution

  • 04049016145554 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-SARS-CoV-2 ELISA (IgA) - 04049016145547

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2606-9601 A
Not in Commercial Distribution

  • 04049016145547 ()


  • SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-SARS-CoV-2 S1 Curve ELISA (IgG) - 04049016150244

No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2606-9601-20 G
Not in Commercial Distribution

  • 04049016150244 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Centurion - 00653160089868

HEART PROGRAM BAG
CENTURION MEDICAL PRODUCTS CORPORATION
SB1335
In Commercial Distribution

  • 50653160089863 ()
  • 00653160089868 ()
SB1335

  • First aid kit, non-medicated, single-use

VITROS - 10758750034420

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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