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- MiscellaneousMiscellaneous
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- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections2Product Code
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Show All 55 Submissions
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- DiaSorin Inc.
- Trade Name
- LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
- Generic Name
- Test, hepatitis b (b core, be antigen, be antibody, b core igm)
- Decision Date
- 8/29/2020
- Days to Decision
- 624 days
- Decision Code
- APPR
- FDA Decision
- Approval