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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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Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi.
RANDOX LABORATORIES LIMITED
SR10345
In Commercial Distribution

  • 05055273216387 ()
SR10345

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
YVHS ORTHO SET UP PACK
MEDLINE INDUSTRIES, INC.
DYNJ68430
In Commercial Distribution

  • 40193489465212 ()
  • 10193489465211 ()
DYNJ68430

  • General surgical procedure kit, non-medicated, single-use
Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Cholesterol, HDL, LDL and Triglycerides.
RANDOX LABORATORIES LIMITED
LV10344
In Commercial Distribution

  • 05055273216257 ()
LV10344

  • Multiple lipid analyte IVD, control
Rheumatoid Factor Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Rheumatoid Factor (RF).
RANDOX LABORATORIES LIMITED
LV10343
In Commercial Distribution

  • 05055273216240 ()
LV10343

  • Rheumatoid factor IVD, control
Esoteric Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Acetaminophen, Ammonia, Ethanol, Salicylate, Microalbumin and Urinary Protein assays.
RANDOX LABORATORIES LIMITED
LV10336
In Commercial Distribution

  • 05055273216165 ()
LV10336

  • Multiple-type clinical chemistry analyte profile IVD, control
TOTAL BASIC
MEDLINE INDUSTRIES, INC.
DYNJ907330B
In Commercial Distribution

  • 10193489465143 ()
DYNJ907330B

  • General surgical procedure kit, non-medicated, single-use
TOTAL KNEE
MEDLINE INDUSTRIES, INC.
DYNJ907588C
In Commercial Distribution

  • 10193489465136 ()
DYNJ907588C

  • General surgical procedure kit, non-medicated, single-use
SY TOTAL SHOULDER
MEDLINE INDUSTRIES, INC.
DYNJ905813C
In Commercial Distribution

  • 10193489465082 ()
DYNJ905813C

  • General surgical procedure kit, non-medicated, single-use
BACK PACK
MEDLINE INDUSTRIES, INC.
DYNJV0056T
In Commercial Distribution

  • 40193489464833 ()
  • 10193489464832 ()
DYNJV0056T

  • General surgical procedure kit, non-medicated, single-use
KNEE ARTHROSCOPY
MEDLINE INDUSTRIES, INC.
DYNJ906212B
In Commercial Distribution

  • 10193489464818 ()
DYNJ906212B

  • General surgical procedure kit, non-medicated, single-use
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