• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN
Classification Namesusceptibility test cards, antimicrobial
Generic Nameantimicrobial susceptibility test system-short incubation
Regulation Number866.1640
ApplicantBIOMERIEUX, INC.
PMA NumberN50510
Supplement NumberS133
Date Received04/05/2000
Decision Date06/09/2000
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the antibiotic benzylpenicillin at concentrations of 0. 03, 0. 06, 0. 25 and 0. 5 micrograms/ml to the vitek(r) 2 s. Pneumoniae susceptibility test system. The device, as modified, will be marketed under the trade name vitek(r) 2 s. Pneumoniae susceptibility test cards for use in the vitek(r) 2 system and is indicated for use for the susceptibility testing of streptococcus pneumoniae to benzylpenicillin in the range of <=0. 06 to >=2 micrograms/ml.
-
-