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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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BioSign Flu A+B Nasal Wash/Aspirate Kit - 10743816001485

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

Status Flu A+B Nasal Wash/Aspirate Kit - 10743816001416

Status Flu A+B Nasopharyngeal Wash/Aspirate Kit; 44 Pipettes
PRINCETON BIOMEDITECH CORPORATION
BSP-510AS-04
In Commercial Distribution

  • 10743816001416 ()
BSP-510AS-04

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

Status™ COVID-19/Flu Control - 10743816001614

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

ACCURUN® - 00816784020123

ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0032
In Commercial Distribution

  • 00816784020123 ()
2000-0032

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020062

ACCURUN 1 Series 5600 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0018
In Commercial Distribution

  • 00816784020062 ()
2000-0018

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020055

ACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0010
In Commercial Distribution

  • 00816784020055 ()
2000-0010

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020048

ACCURUN 1 Series 4000 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0008
In Commercial Distribution

  • 00816784020048 ()
2000-0008

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020031

ACCURUN 1 Series 2500 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0002
In Commercial Distribution

  • 00816784020031 ()
2000-0002

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020024

ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0001
In Commercial Distribution

  • 00816784020024 ()
2000-0001

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020888

ACCURUN 1 Series 2700 Multi-Marker Positive Control 3 x 1 mL
Lgc Clinical Diagnostics, Inc.
2000-0006
In Commercial Distribution

  • 00816784020888 ()
2000-0006

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020871

ACCURUN 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0005
In Commercial Distribution

  • 00816784020871 ()
2000-0005

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020789

ACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0022
In Commercial Distribution

  • 00816784020789 ()
2000-0022

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020772

ACCURUN 1 Series 5100 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0017
In Commercial Distribution

  • 00816784020772 ()

  • Total Volume: 42 Milliliter
2000-0017

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020765

ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0016
In Commercial Distribution

  • 00816784020765 ()

  • Total Volume: 15 Milliliter
2000-0016

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020741

No Description
Lgc Clinical Diagnostics, Inc.
2000-0079
In Commercial Distribution

  • 00816784020741 ()


  • Multiple blood-borne virus antigen/antibody IVD, control

ABBOTT PRISM - 00380740039219

ABBOTT PRISM Positive Run Control Kit
ABBOTT LABORATORIES
3E60-11
Not in Commercial Distribution

  • 00380740039219 ()
03E6011

  • Multiple blood-borne virus antigen/antibody IVD, control

ABBOTT PRISM - 00380740038403

ABBOTT PRISM Run Control Kit
ABBOTT LABORATORIES
3E60-10
Not in Commercial Distribution

  • 00380740038403 ()
03E6010

  • Multiple blood-borne virus antigen/antibody IVD, control

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) - 04049016124894

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-6401-8 G
In Commercial Distribution

  • 04049016124894 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG) - 04049016124887

No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1300-1601-8 G
In Commercial Distribution

  • 04049016124887 ()


  • Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

OraSure Quickflu Nasopharyngeal Wash / Aspirate - 00608337000047

No Description
Orasure Technologies, Inc.
1001-0321
In Commercial Distribution

  • 00608337000047 ()


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