FDA.reportPublic FDA data

PMA P000014

Device
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
Applicant
Ortho-Clinical Diagnostics, Inc.
PMA number
P000014
Supplement
S036
Product code
LOM
Decision date
2020-10-22
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Amendment of the assay specific release for sale limits and customer calibration limits used with Immunodiagnostic Products, VITROS Anti-HBs reagent pack and calibrators.

Current openFDA PMA Record#

Device
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
Applicant
Ortho-Clinical Diagnostics, Inc.
PMA number
P000014
Supplement
S036
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2020-10-22
Decision code
OK30
Date received
2020-09-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Amendment of the assay specific release for sale limits and customer calibration limits used with Immunodiagnostic Products, VITROS Anti-HBs reagent pack and calibrators.