PMA P890014S008

Device: ETI-HA-IGMK PLUS KIT
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S008
Product code: LOL
Decision date: 2005-12-14
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: APPROVAL FOR CHANGE TO THE ASSAY CUTOFF CALCULATION THAT IS DESIGNED TO REDUCE THE NUMBER OF LOW LEVEL, NON-CLINICALLY RELEVANT POSITIVE RESULTS REPORTED BY THE ETI-HA-IGMK PLUS ASSAY.

Current openFDA PMA Record#

Device: ETI-HA-IGMK PLUS KIT
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S008
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2005-12-14
Decision code: APPR
Date received: 2005-07-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGE TO THE ASSAY CUTOFF CALCULATION THAT IS DESIGNED TO REDUCE THE NUMBER OF LOW LEVEL, NON-CLINICALLY RELEVANT POSITIVE RESULTS REPORTED BY THE ETI-HA-IGMK PLUS ASSAY.