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PMA P160019S010

Device
Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II
Applicant
Roche Diagnostics, Inc.
PMA number
P160019
Supplement
S010
Product code
LOM
Decision date
2020-02-27
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement
Approval for (1) the inclusion of a biotin scavenger antibody in Reagent 2 of the test kit to increase the biotin tolerance of the assay and (2) the proposed labeling changes for Elecsys HBsAg II and Elecsys HBsAg Confirmatory Test.

Current openFDA PMA Record#

Device
Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II
Applicant
Roche Diagnostics, Inc.
PMA number
P160019
Supplement
S010
Product code
LOM
Generic name
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date
2020-02-27
Decision code
APPR
Date received
2019-09-03
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for (1) the inclusion of a biotin scavenger antibody in Reagent 2 of the test kit to increase the biotin tolerance of the assay and (2) the proposed labeling changes for Elecsys HBsAg II and Elecsys HBsAg Confirmatory Test.