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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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ACCURUN® - 00816784020215

ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2010-0013
In Commercial Distribution

  • 00816784020215 ()

  • Total Volume: 5 Milliliter
2010-0013

  • Negative control immunoglobulin IVD

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

PreciControl Syphilis - 07613336183175

Syphilis PC Elecsys
Roche Diagnostics GmbH
06923364162
In Commercial Distribution

  • 07613336183175 ()
06923364162

  • Treponema pallidum total antibody IVD, control

PreciControl Anti-CMV - 07613336183151

No Description
Roche Diagnostics GmbH
04784600162
In Commercial Distribution

  • 07613336183151 ()
04784600162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Elecsys Syphilis - 07613336183083

No Description
Roche Diagnostics GmbH
09015051162
In Commercial Distribution

  • 07613336228463 ()
  • 07613336183083 ()
09015051162

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
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