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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 315 Series 400 HIV-1 RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0092
In Commercial Distribution

  • 00816784020574 ()
2020-0092

  • HIV1 nucleic acid IVD, control
ACCURUN 315 Series 200 HIV-1 RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0090
In Commercial Distribution

  • 00816784020567 ()
2020-0090

  • HIV1 nucleic acid IVD, control
ACCURUN 315 Series 150 HIV-1 RNA 10 x 1.2 mL
Lgc Clinical Diagnostics, Inc.
2020-0087
In Commercial Distribution

  • 00816784020550 ()
2020-0087

  • HIV1 nucleic acid IVD, control
ACCURUN 305 Series 400 HCV RNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0085
In Commercial Distribution

  • 00816784020536 ()
2020-0085

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 305 Series 300 HCV RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0083
In Commercial Distribution

  • 00816784020529 ()
2020-0083

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 305 Series 100 HCV RNA 5 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0080
In Commercial Distribution

  • 00816784020512 ()
2020-0080

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 305 Series 150 HCV RNA Positive Control 10 x 1.2 mL
Lgc Clinical Diagnostics, Inc.
2020-0078
In Commercial Distribution

  • 00816784020505 ()
2020-0078

  • Hepatitis C virus nucleic acid IVD, control
ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0093
In Commercial Distribution

  • 00816784020475 ()

  • Total Volume: 6 Milliliter
2015-0093

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0092
In Commercial Distribution

  • 00816784020468 ()

  • Total Volume: 42 Milliliter
2015-0092

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0090
In Commercial Distribution

  • 00816784020451 ()
2015-0090

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, control
ACCURUN 145 CMV IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0087
In Commercial Distribution

  • 00816784020437 ()
2015-0087

  • Cytomegalovirus (CMV) antigen IVD, control
ACCURUN 106 Series 1000 HIV-1 Ag 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0066
In Commercial Distribution

  • 00816784020260 ()
2015-0066

  • HIV1 antigen IVD, control
ACCURUN 106 Series 1000 HIV-1 Ag 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0065
In Commercial Distribution

  • 00816784020253 ()
2015-0065

  • HIV1 antigen IVD, control
ACCURUN 1 Multi-Marker Negative Control 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2010-0015
In Commercial Distribution

  • 00816784020222 ()

  • Total Volume: 42 Milliliter
2010-0015

  • Negative control immunoglobulin IVD
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 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 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 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 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 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
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