PMA P050048S002

Device: BIO-RAD MONOLISA ANTI-HBS EIA
Applicant: Bio-Rad Laboratories
PMA number: P050048
Supplement: S002
Product code: LOM
Decision date: 2010-03-12
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR THE MONOLISA ANTI-HBS EIA PACKAGE INSERT IN ORDER TO ADD THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, WITH UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED.

Current openFDA PMA Record#

Device: BIO-RAD MONOLISA ANTI-HBS EIA
Applicant: Bio-Rad Laboratories
PMA number: P050048
Supplement: S002
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2010-03-12
Decision code: APPR
Date received: 2008-09-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MONOLISA ANTI-HBS EIA PACKAGE INSERT IN ORDER TO ADD THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, WITH UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED.