PMA P870049S027
- Device
- MICROSCAN(R) RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S027
- Product code
- LON
- Decision date
- 1998-06-30
- 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 to confirm results for the testing of Staphylococcus spp. with the antibiotic Vancomycin. The device, as modified, will be marketed under the trade name MicroScan(R) Rapid Fluorogenic.
Current openFDA PMA Record#
- Device
- MICROSCAN(R) RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S027
- Product code
- LON
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Decision date
- 1998-06-30
- Decision code
- APPR
- Date received
- 1998-06-09
- 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 to confirm results for the testing of Staphylococcus spp. with the antibiotic Vancomycin. The device, as modified, will be marketed under the trade name MicroScan(R) Rapid Fluorogenic.