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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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STAPH BROTH 5ML
EDGE BIOLOGICALS, INC.
T0781
Not in Commercial Distribution

  • B645T07811 ()
  • B645T0781 ()


  • Differential/selective broth culture medium IVD
PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (3 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
ENTOPSIS, LLC
Universal Viral Transport (100x 3 mL)
Not in Commercial Distribution

  • B55088800003 ()
  • B550888100038 ()
88810003

  • Viral transport medium IVD
PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880200 ()
888020

  • Viral transport medium IVD
PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880050 ()
888005

  • Viral transport medium IVD
PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880010 ()
888001

  • Viral transport medium IVD
PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (1.5 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
ENTOPSIS, LLC
Universal Viral Transport (100x 1.5 mL)
Not in Commercial Distribution

  • B550888100158 ()
  • B55088800015 ()
88810015

  • Viral transport medium IVD
O.C.T. Compound
SAKURA FINETEK U.S.A., INC.
4583
In Commercial Distribution

  • 10615233078657 ()
  • 00615233078650 ()
4583

  • Tissue freezing/embedding medium IVD
No Description
Pretium Canada Packaging ULC
S160-URETH
In Commercial Distribution

  • 00840165400594 ()
  • 00840165400587 ()
  • 10840165400584 ()


  • General specimen collection kit IVD, clinical
Starswab Multitrans System with minitip flocked swab applicator and 1 ml media fill.
Pretium Canada Packaging ULC
S160-NASO-1
In Commercial Distribution

  • 00840165400570 ()
  • 00840165400563 ()
  • 10840165400560 ()


  • General specimen collection kit IVD, clinical
Starswab Multitrans System with minitip flocked swab applicator.
Pretium Canada Packaging ULC
S160-NASO
In Commercial Distribution

  • 00840165400556 ()
  • 00840165400549 ()
  • 10840165400546 ()


  • General specimen collection kit IVD, clinical
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