PMA P890014S005

Device: DIASORIN ETI-HA-IGMK PLUS
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S005
Product code: LOL
Decision date: 2003-05-06
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: CHANGE IN THE QUANTITY OF NON-SPECIFIC MOUSE IGG USED IN THE PREPARATION OF THE SAMPLE DILUENT, POSITIVE CONTROL AND NEGATIVE CONTROL KIT REAGENTS OF THE DIASORIN ETI-HA-IGMK PLUS.

Current openFDA PMA Record#

Device: DIASORIN ETI-HA-IGMK PLUS
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S005
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2003-05-06
Decision code: OK30
Date received: 2003-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE QUANTITY OF NON-SPECIFIC MOUSE IGG USED IN THE PREPARATION OF THE SAMPLE DILUENT, POSITIVE CONTROL AND NEGATIVE CONTROL KIT REAGENTS OF THE DIASORIN ETI-HA-IGMK PLUS.