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Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) — Ortho-Clinical Diagnostics, Inc. (PMA P000014)

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) — Ortho-Clinical Diagnostics, Inc. (PMA P000014) 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: Ortho-Clinical Diagnostics, Inc.; Clearance trac

Device nameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
ApplicantOrtho-Clinical Diagnostics, Inc.
Clearance trackPMA
Submission numberP000014
DecisionOK30
Decision date2020-10-22
Date received2020-09-22
Product codeLOM
Device class2
Medical specialtyMicrobiology
Applicant locationNY
SourceopenFDA device

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