PMA P080026S002

Device: ABBOTT REALTIME HBV ASSAY
Applicant: Abbott Molecular, Inc.
PMA number: P080026
Supplement: S002
Product code: MKT
Decision date: 2011-11-30
Classification: Hepatitis Viral B Dna Detection
Generic name: Hepatitis Viral B DNA Detection
Approval order statement: APPROVAL FOR A RAW MATERIAL CHANGE FOR TWO OF THE MICROVIALS USED TO MANUFACTURE THE REAGENT COMPONENTS IN THE ABBOTT REALTIME HBV AMPLIFICATION KIT WITHIN THE ABBOTT REALTIME HBV ASSAY.

Current openFDA PMA Record#

Device: ABBOTT REALTIME HBV ASSAY
Applicant: Abbott Molecular, Inc.
PMA number: P080026
Supplement: S002
Product code: MKT
Generic name: Hepatitis Viral B DNA Detection
Decision date: 2011-11-30
Decision code: APPR
Date received: 2011-07-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A RAW MATERIAL CHANGE FOR TWO OF THE MICROVIALS USED TO MANUFACTURE THE REAGENT COMPONENTS IN THE ABBOTT REALTIME HBV AMPLIFICATION KIT WITHIN THE ABBOTT REALTIME HBV ASSAY.