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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 LEVEL 1
UTAK LABORATORIES, INC.
DAU 1 F HCMC
In Commercial Distribution

  • B800DAU1FHCMC5 ()
  • B800DAU1FHCMC0 ()

  • Total Volume: 10 Milliliter
DAU 1 F HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DAU 1 F APS
In Commercial Distribution

  • B800DAU1FAPS5 ()
  • B800DAU1FAPS0 ()

  • Total Volume: 1 Milliliter
DAU 1 F APS

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE PLUS LEVEL 1
UTAK LABORATORIES, INC.
DAU + 1 F APC
In Commercial Distribution

  • B800DAU1FAPC5 ()
  • B800DAU1FAPC0 ()

  • Total Volume: 2 Milliliter
DAU + 1 F APC

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE QC LEVEL 2
UTAK LABORATORIES, INC.
DA SMX-OF QC 2
In Commercial Distribution

  • B800DASMXOFQC25 ()
  • B800DASMXOFQC20 ()

  • Total Volume: 4 Milliliter
DA SMX-OF QC 2

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE QC LEVEL 1
UTAK LABORATORIES, INC.
DA SMX-OF QC 1
In Commercial Distribution

  • B800DASMXOFQC15 ()
  • B800DASMXOFQC10 ()

  • Total Volume: 4 Milliliter
DA SMX-OF QC 1

  • Multiple therapeutic drugs/drugs of abuse IVD, control
New Easy-to-Use Disk Format. Hardy Diagnostics now offers a convenient way of testing ß-lactamase activity in bacteria. The rapid Nitrocef test consists of a disk 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 Disk test 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. These HardyDisks™ are packages loose in a glass vial.
HARDY DIAGNOSTICS
Z7301
In Commercial Distribution

  • 00816576028887 ()
  • 00816576028894 ()
Z7301

  • Beta-lactamase production microbial reagent IVD
Positive and Negative Oral Fluid Controls
BRANAN MEDICAL CORPORATION
OC001
Not in Commercial Distribution

  • 00816555020222 ()
OC001

  • Multiple drugs of abuse IVD, calibrator
Licox® Complete Brain Tunnelling Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IT2
Not in Commercial Distribution

  • M273IT21 ()
  • 10381780041207 ()

  • 130 mm x 35 mm x 313 mm
IT2

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IP2P
Not in Commercial Distribution

  • M273IP2P1 ()
  • 10381780041191 ()

  • 130 mm x 35 mm x 313 mm
IP2P

  • Intracerebral sensor catheter, short-term
Licox® Complete Brain Probe Kit
GMS, Gesellschaft für medizinische Sondentechnik mbH
IP1P
Not in Commercial Distribution

  • M273IP1P1 ()
  • 10381780041184 ()

  • 130 mm x 35 mm x 313 mm
IP1P

  • Intracerebral sensor catheter, short-term
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