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Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) — Roche Diagnostics Corp. (PMA P100031)

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) — Roche Diagnostics Corp. (PMA P100031) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Applicant: Roche Diagnostics Corp.; Clearance track: PMA.

Device nameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
ApplicantRoche Diagnostics Corp.
Clearance trackPMA
Submission numberP100031
DecisionOK30
Decision date2023-10-31
Date received2023-09-21
Product codeLOM
Device class2
Medical specialtyMicrobiology
Applicant locationIN
SourceopenFDA device

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