PMA P890019S006

Device: AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS
Applicant: Diasorin
PMA number: P890019
Supplement: S006
Product code: LOL
Decision date: 2001-02-02
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: APPROVAL FOR A CHANGE IN PURIFICATION PROCESS AND STORAGE CONDITIONS OF COMPONENTS OF THE AB-HAVK RIA DEVICE AND THE ETI-AB-HAVK PLUS DEVICE.

Current openFDA PMA Record#

Device: AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS
Applicant: Diasorin
PMA number: P890019
Supplement: S006
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2001-02-02
Decision code: APPR
Date received: 2000-10-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE IN PURIFICATION PROCESS AND STORAGE CONDITIONS OF COMPONENTS OF THE AB-HAVK RIA DEVICE AND THE ETI-AB-HAVK PLUS DEVICE.