PMA P060034S002

Device: BIO-RAD MONOLISA ANTI-HBC IGM EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060034
Supplement: S002
Product code: LOM
Decision date: 2009-02-20
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR AN AMENDMENT TO THE PACKAGE INSERT WITH THE ADDITION OF THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED FOR THE DEVICE.

Current openFDA PMA Record#

Device: BIO-RAD MONOLISA ANTI-HBC IGM EIA
Applicant: Bio-Rad Laboratories, Inc.
PMA number: P060034
Supplement: S002
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2009-02-20
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 AN AMENDMENT TO THE PACKAGE INSERT WITH THE ADDITION OF THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED FOR THE DEVICE.