PMA P870049S030
- Device
- MICROSCAN(R) RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S030
- Product code
- LON
- Decision date
- 2000-06-05
- Classification
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Approval order statement
- APPROVAL FOR LABELING CHANGE THAT ADDS A CONTRAINDICATION TO THE GRAM NEGATIVE MICROSCAN RAPID FLUOROGENIC PANELS OF "DO NOT REPORT" WHEN TESTING ALL GRAM NEGATIVE ORGANISMS WITH CEFOPERAZONE USING EITHER THE MIC OR BREAKPOINT FORMATS.
Current openFDA PMA Record#
- Device
- MICROSCAN(R) RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S030
- Product code
- LON
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Decision date
- 2000-06-05
- Decision code
- APPR
- Date received
- 2000-05-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGE THAT ADDS A CONTRAINDICATION TO THE GRAM NEGATIVE MICROSCAN RAPID FLUOROGENIC PANELS OF "DO NOT REPORT" WHEN TESTING ALL GRAM NEGATIVE ORGANISMS WITH CEFOPERAZONE USING EITHER THE MIC OR BREAKPOINT FORMATS.