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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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DRUGS OF ABUSE QC LOW
UTAK LABORATORIES, INC.
DA QC LOW U F UMHC
In Commercial Distribution

  • B800DAQCLOWUFUMHC5 ()
  • B800DAQCLOWUFUMHC0 ()

  • Total Volume: 20 Milliliter
DA QC LOW U F UMHC

  • Multiple-type clinical chemistry analyte profile IVD, control
ONPG-PDA, for rapid lactose fermentation and phenylalanine deaminase detection, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 To aid in the rapid identification of Salmonella and Shigella spp. in clinical specimens. Detects beta-galactosidase and phenylalanine deaminase activity.
HARDY DIAGNOSTICS
R93
In Commercial Distribution

  • 00819398023740 ()
  • 00819398023757 ()
R93

  • Differential/selective broth culture medium IVD
ONPG, Rapid Test Broth, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 For the rapid determination of beta-Galactosidase activity of gram negative bacilli.
HARDY DIAGNOSTICS
R92
In Commercial Distribution

  • 00819398023726 ()
  • 00819398023733 ()
R92

  • Differential/selective broth culture medium IVD
Nitrocef Matchbook™, chromogenic nitrocefin test for beta lactamase, on paper strip, 10 tests per package New Easy-to-Use MatchBook Format. Hardy Diagnostics now offers a more convenient way of testing ß-lactamase activity in bacteria. The new Nitrocef MatchBook™ is a rapid test that allows you to quickly pick your colonies and perform the test at the same time! Easier and faster than a disk! The rapid Nitrocef test consists of a paper match-stick that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms: • Neisseria gonorrhoeae • Haemophilus spp. • Moraxella (Branhamella) catarrhalis • Staphylococcus spp. • Enterococcus spp. • Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella) The rapid Nitrocef MatchBookTM can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. Now contains a larger reaction pad.
HARDY DIAGNOSTICS
Z108
Not in Commercial Distribution

  • 00819398027526 ()
  • 00819398028547 ()
Z108

  • Beta-lactamase detection reagent IVD
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA M F HD
In Commercial Distribution

  • B800DAMFHD5 ()
  • B800DAMFHD0 ()

  • Total Volume: 5 Milliliter
DA M F HD

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LOW
UTAK LABORATORIES, INC.
DA LOW V2 WB F BTL
In Commercial Distribution

  • B800DALOWV2WBFBTL5 ()
  • B800DALOWV2WBFBTL0 ()

  • Total Volume: 1 Milliliter
DA LOW V2 WB F BTL

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE HIGH
UTAK LABORATORIES, INC.
DA HIGH V2 WB F BTL
In Commercial Distribution

  • B800DAHIGHV2WBFBTL5 ()
  • B800DAHIGHV2WBFBTL0 ()

  • Total Volume: 1 Milliliter
DA HIGH V2 WB F BTL

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE CUTOFF
UTAK LABORATORIES, INC.
DA CUT V2 S F PL
In Commercial Distribution

  • B800DACUTV2SFPL5 ()
  • B800DACUTV2SFPL0 ()

  • Total Volume: 5 Milliliter
DA CUT V2 S F PL

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE PLUS LEVEL 4
UTAK LABORATORIES, INC.
DA+4 WB V3 IMMUN
In Commercial Distribution

  • B800DA4WBV3IMMUN5 ()
  • B800DA4WBV3IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+4 WB V3 IMMUN

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE PLUS LEVEL 4
UTAK LABORATORIES, INC.
DA+4 WB V2 IMMUN
In Commercial Distribution

  • B800DA4WBV2IMMUN5 ()
  • B800DA4WBV2IMMUN0 ()

  • Total Volume: 1 Milliliter
DA+4 WB V2 IMMUN

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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