PMA P160019S008

Device

Elecsys HBsAg II (100/200 tests)

Applicant

Roche Diagnostics, Inc.

PMA number

P160019

Supplement

S008

Product code

LOM

Decision date

2018-11-06

Classification

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

Generic name

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Approval order statement

Addition of a secondary manufacturer/supplier of a component raw material.

Summary

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