PMA N50510S107

Device: VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S107
Product code: LTW
Decision date: 2000-01-21
Classification: Susceptibility Test Cards, Antimicrobial
Generic name: Susceptibility test cards, antimicrobial
Approval order statement: Approval for the addition of the antibiotic nitrofurantoin at concentrations of 16, 32, and 64 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the tradename Vitek 2 and is indicated for use in Vitek 2 Gram Negative Susceptibility Test Card for the susceptibility testing of gram negative isolates to nitrofurantoin in the range of <= 16 to >= 512ug/ml.

Current openFDA PMA Record#

Device: VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN
Applicant: Biomerieux Vitek, Inc.
PMA number: N50510
Supplement: S107
Product code: LTW
Generic name: Susceptibility test cards, antimicrobial
Decision date: 2000-01-21
Decision code: APPR
Date received: 1999-08-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of the antibiotic nitrofurantoin at concentrations of 16, 32, and 64 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the tradename Vitek 2 and is indicated for use in Vitek 2 Gram Negative Susceptibility Test Card for the susceptibility testing of gram negative isolates to nitrofurantoin in the range of = 512ug/ml.