PMA P870049S031

Device: MICROSCAN RAPID FLUOROGENIC PANELS
Applicant: Dade Intl., Inc.
PMA number: P870049
Supplement: S031
Product code: LON
Decision date: 2001-11-09
Generic name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Approval order statement: APPROVAL FOR LABELING CHANGES TO STRENGTHEN CONTRAINDICATIONS TO THE RAPID GRAM NEGATIVE PROCEDURAL MANUALS FOR BOTH MIC AND BREAKPOINT FORMATS, WHICH DESCRIBES A LIMITATION FOR PERFORMANCE CHARACTERISTICS FOR ESBL PRODUCING ORGANISMS AND A LIMITATION FOR THOSE ORGANISMS (E.G., ENTEROBACTER SPECIES) WHICH EXPRESS INDUCIBLE BETA-LACTAMASE ENZYMES.

Current openFDA PMA Record#

Device: MICROSCAN RAPID FLUOROGENIC PANELS
Applicant: Dade Intl., Inc.
PMA number: P870049
Supplement: S031
Product code: LON
Generic name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Decision date: 2001-11-09
Decision code: APPR
Date received: 2001-10-12
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO STRENGTHEN CONTRAINDICATIONS TO THE RAPID GRAM NEGATIVE PROCEDURAL MANUALS FOR BOTH MIC AND BREAKPOINT FORMATS, WHICH DESCRIBES A LIMITATION FOR PERFORMANCE CHARACTERISTICS FOR ESBL PRODUCING ORGANISMS AND A LIMITATION FOR THOSE ORGANISMS (E.G., ENTEROBACTER SPECIES) WHICH EXPRESS INDUCIBLE BETA-LACTAMASE ENZYMES.