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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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DENVER VA DRUGS OF ABUSE CAL 3
UTAK LABORATORIES, INC.
DEN VA DAU CAL 3
In Commercial Distribution

  • B800DENVADAUCAL35 ()
  • B800DENVADAUCAL30 ()

  • Total Volume: 1 Milliliter
DEN VA DAU CAL 3

  • Multiple-therapy therapeutic drug monitoring IVD, control
DENVER VA DRUGS OF ABUSE CAL 2
UTAK LABORATORIES, INC.
DEN VA DAU CAL 2
In Commercial Distribution

  • B800DENVADAUCAL25 ()
  • B800DENVADAUCAL20 ()

  • Total Volume: 1 Milliliter
DEN VA DAU CAL 2

  • Multiple-therapy therapeutic drug monitoring IVD, control
DENVER VA DRUGS OF ABUSE CAL 1
UTAK LABORATORIES, INC.
DEN VA DAU CAL 1
In Commercial Distribution

  • B800DENVADAUCAL15 ()
  • B800DENVADAUCAL10 ()

  • Total Volume: 1 Milliliter
DEN VA DAU CAL 1

  • Multiple-therapy therapeutic drug monitoring IVD, control
DELTA-9-THC 8 NG/ML
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9THC8NGML5 ()
  • B800DELTA9THC8NGML0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9OMEGA5 ()
  • B800DELTA9OMEGA0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA WB F ODPS
In Commercial Distribution

  • B800DAWBFODPS5 ()
  • B800DAWBFODPS0 ()

  • Total Volume: 3 Milliliter
DA WB F ODPS

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA WB 2PT V2 SDHL
In Commercial Distribution

  • B800DAWB2PTV2SDHL5 ()
  • B800DAWB2PTV2SDHL0 ()

  • Total Volume: 2 Milliliter
DA WB 2PT V2 SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA V F WB SCCCL
In Commercial Distribution

  • B800DAVFWBSCCCL5 ()
  • B800DAVFWBSCCCL0 ()

  • Total Volume: 50 Milliliter
DA V F WB SCCCL

  • Multiple-type clinical chemistry analyte profile IVD, control
BLANK HAIR MATRIX
UTAK LABORATORIES, INC.
034765-0001
In Commercial Distribution

  • B80003476500010 ()

  • Total Volume: 100 Milliliter
BLK HAIR OL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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
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