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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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Oral Fluid, 2X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200108
In Commercial Distribution

  • 00810042682610 ()
20200108

  • Multiple drugs of abuse IVD, control
Oral Fluid, Cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200107
In Commercial Distribution

  • 00810042682603 ()
20200107

  • Multiple drugs of abuse IVD, control
Oral Fluid, Cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
20200103
In Commercial Distribution

  • 00810042682597 ()
20200103

  • Multiple drugs of abuse IVD, control
NW DOA Panel, +25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008623
In Commercial Distribution

  • 00810042684348 ()
18008623

  • Multiple drugs of abuse IVD, control
NW DOA Panel, -25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008622
In Commercial Distribution

  • 00810042684331 ()
18008622

  • Multiple drugs of abuse IVD, control
SERIES V-H, Cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
19555252
In Commercial Distribution

  • 00810042683921 ()
19555252

  • Multiple drugs of abuse IVD, control
Schiff's Reagent for Histological Staining
TRANSENE COMPANY, INC.
1
In Commercial Distribution

  • SO429852042008 ()

  • Total Volume: 1 Gallon
  • Total Volume: 1 Quart
  • Total Volume: 1 Pint
  • Total Volume: 8 Fluid Ounce
  • Total Volume: 4 Fluid Ounce
SO-429

  • Biological stain IVD
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
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0063
In Commercial Distribution

  • 00816784020932 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0065
In Commercial Distribution

  • 00816784020925 ()


  • Hepatitis B virus antigen/antibody marker IVD, control
  • Multiple blood-borne virus antigen/antibody IVD, control
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