PMA P870049S028
- Device
- MICROSCAN RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S028
- Product code
- LON
- Decision date
- 1999-01-25
- Classification
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Approval order statement
- Approval for the addition of a limitation to use an alternative method for testing of Proteus mirabilis and Enterobacter spp. with the antibiotic Cefazolin in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.
Current openFDA PMA Record#
- Device
- MICROSCAN RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S028
- Product code
- LON
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Decision date
- 1999-01-25
- Decision code
- APPR
- Date received
- 1999-01-04
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a limitation to use an alternative method for testing of Proteus mirabilis and Enterobacter spp. with the antibiotic Cefazolin in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.