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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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D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0290
In Commercial Distribution

  • ENTIINFG02900 ()
INFG0290

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Lgc Clinical Diagnostics, Inc.
2000-0100
In Commercial Distribution

  • 00860006589783 ()


  • Multiple blood-borne virus antigen/antibody IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0079
In Commercial Distribution

  • 00860006589776 ()


  • Multiple blood-borne virus antigen/antibody IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0080
In Commercial Distribution

  • 00860006589707 ()


  • Multiple blood-borne virus antigen/antibody IVD, control
VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000539
In Commercial Distribution

  • 03610520530146 ()
12000539

  • Multiple blood-borne virus antigen/antibody IVD, control
VIROTROL PLUS-R (An unassayed (human) serology control)
BIO-RAD LABORATORIES, INC.
12000538
In Commercial Distribution

  • 03610520530139 ()
12000538

  • Multiple blood-borne virus antigen/antibody IVD, control
Status™ COVID-19/Flu A&B Control Swab Kit (5 Positive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-511C-00
In Commercial Distribution

  • 10743816001614 ()
BSP-511C-00

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • Influenza A/B virus antigen IVD, control
BioSign Flu A+B Nasopharyngeal Wash/Aspirate Kit, 50 pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-07
In Commercial Distribution

  • 10743816001485 ()
BSP-510AS-07

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
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