FDA.reportPublic FDA data

PMA P030056S016

Device
Atellica IM Hepatitis C (aHCV) Assay
Applicant
Siemens Healthcare Diagnostics
PMA number
P030056
Supplement
S016
Product code
MZO
Decision date
2020-04-03
Generic name
Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).

Current openFDA PMA Record#

Device
Atellica IM Hepatitis C (aHCV) Assay
Applicant
Siemens Healthcare Diagnostics
PMA number
P030056
Supplement
S016
Product code
MZO
Generic name
Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date
2020-04-03
Decision code
OK30
Date received
2020-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the manufacturing process to add a second manufacturing site for optional sample handling subsystem (Atellica Direct Load) for the Atellica IM Analyzer (Immunoassay Module).