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- QGNLateral Flow Immunochromatography Assay For Host Infection Biomarkers2Product Code
- PBKNon-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set2Product Code
- OBFAssay, Genotyping, Hepatitis C Virus3Product Code
- PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel2Product Code
- QHMSerology Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsUProduct Code
- PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System2Product Code
- PRAVariola Virus Nucleic Acid-Based Detection Assay2Product Code
- PRHPositive Blood Culture Identification And Ast Kit2Product Code
- PVQRickettsia Spp. Nucleic Acid Based Detection Assay2Product Code
- PYNFish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.2Product Code
- QAACoccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens2Product Code
- QBDMicrobial Nucleic Acid Storage And Stabilization Device2Product Code
- QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates2Product Code
- QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection2Product Code
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections2Product Code
- QFAAssay For Detection Of Proteases In Chronic Wounds2Product Code
- QFOZika Virus Serological Reagents2Product Code
- QHONucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsUProduct Code
- QIDDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens2Product Code
- QNJMass Spectrometry, Microorganism Identification, Blood Culture2Product Code
- MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus3Product Code
- NCDTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis3Product Code
- NWYTest, Qualitative, Detection Of Dengue Igm And Igg AntibodiesNProduct Code
- QPODevice To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples2Product Code
- QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry2Product Code
- PZFMers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System2Product Code
- QDSMers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System2Product Code
- LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)3Product Code
- LQIHepatitis Delta Serological Reagents3Product Code
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- MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg3Product Code
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- OJOEnzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of MycobacteriaNProduct Code
- ORLWhole Blood Pre-Treatment T-Cell Enrichment Reagent3Product Code
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- PCYInvestigational Use Only - MicrobiologyNProduct Code
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- POGReagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic AcidNProduct Code
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- QHVMultiple Osteoarticular Pathogen Antigen KitNProduct Code
- QIMBartonella Spp. Serological ReagentsNProduct Code
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- QIPRickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological ReagentsNProduct Code
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- QJRReagents, 2019-Novel Coronavirus Nucleic AcidNProduct Code
- QKOReagent, Coronavirus SerologicalNProduct Code
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- QLTCovid-19 Multi-Analyte Respiratory Panel Nucleic Acid DevicesNProduct Code
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- QSNOrthopedic Infection Microbial Multiplex Nucleic Acid Detection System2Product Code
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- QTPReagents, Monkeypox Virus Nucleic Acid.NProduct Code
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- QWBOver-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens2Product Code
- QVRMultiplex Nucleic Acid Detection System For Biothreat Agents2Product Code
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- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings2Product Code
- QVPSars-Cov-2 Serology Test2Product Code
- QWRSimple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings2Product Code
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- QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home2Product Code
- QYTOver-The-Counter Covid-19 Antigen Test2Product Code
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- SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples2Product Code
- SBPSimple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test2Product Code
- SBTDevice To Detect Microbial Colonization Directly From Clinical Specimens.2Product Code
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- SCAMulti-Analyte Respiratory Virus Antigen Detection Test2Product Code
- SDMNucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/PsUProduct Code
- SDNSerology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/PsUProduct Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
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Alinity m CMV
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Abbott Molecular, Inc.
- Trade Name
- Alinity m CMV
- Generic Name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision Date
- 5/5/2022
- Days to Decision
- 338 days
- Decision Code
- APPR
- FDA Decision
- Approval