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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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Trinity Biotech - 05391516747998

Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution

  • 05391516747998 ()
B1029-70D

  • Clostridium difficile toxin A/B antigen IVD, reagent

OraSure QuickFlu Positive and Negative Control Kit - 00608337000054

No Description
Orasure Technologies, Inc.
1001-0323
In Commercial Distribution

  • 00608337000054 ()


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

BioSign Flu Controls - 10743816001492

BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution

  • 10743816001492 ()
BSP-510C-03

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

Status Flu Controls - 10743816001423

Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution

  • 10743816001423 ()
BSP-510C-02

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

Trinity Biotech - 05391516748773

Uni-Gold™ C. difficile Toxin A/B, 20 Tests
MARDX DIAGNOSTICS, INC.
1206630
In Commercial Distribution

  • 05391516748773 ()
1206630

  • Clostridium difficile toxin A/B antigen IVD, kit, agglutination, rapid

Rapid Response - 00722066001974

Rapid Response Respiratory Syncytial Virus Test Cassette - 30 tests/ kit are for the qualitative detection of Respiratory Syncytial Virus Antigen in Nasopharyngeal specimens.
BTNX Inc
RSV-19C30
In Commercial Distribution

  • 00722066001974 ()
  • 00722066004265 ()
RSV-19C30

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid

Sklar® - 10649111127106

STEVENS TENO SCISS STR 4.5 B/B
SKLAR CORPORATION
64-1242
In Commercial Distribution

  • 10649111127106 ()


  • Ophthalmic tenotomy scissors

Sklar® - 10649111165054

STEVENS TENOT SCISS CVD B/B TC
SKLAR CORPORATION
16-2731
In Commercial Distribution

  • 10649111165054 ()


  • Ophthalmic tenotomy scissors

Sklar® - 10649111164965

STEVENS TENOT SCISS STR B/B TC
SKLAR CORPORATION
16-2730
In Commercial Distribution

  • 10649111164965 ()


  • Ophthalmic tenotomy scissors

Sklar® - 10649111142406

STEV TENOT SCISS CVD B/B 4.5
SKLAR CORPORATION
64-1342
In Commercial Distribution

  • 10649111142406 ()


  • Ophthalmic tenotomy scissors
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