Anesthesiology
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- ChemistryReview Panel
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- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- MiscellaneousMiscellaneous
- 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
- P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT QualitAPPRPMA Approval
- P210019ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)APPRPMA Approval
- P200017ADVIA Centaur Anti-HBe2 (aHBe2) assayAPPRPMA Approval
- P190034Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheckAPPRPMA Approval
- P190005Elecsys Anti-HBe, PreciControl Anti-HBeAPPRPMA Approval
- P190017LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory TestAPPRPMA Approval
- P180049LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBeAPPRPMA Approval
- P180048LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAgAPPRPMA Approval
- P180045LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgMAPPRPMA Approval
- P180039LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs VerifiersAPPRPMA Approval
Show All 55 Submissions
- LQIHepatitis Delta Serological Reagents3Product Code
- MAQKit, Dna Detection, Human Papillomavirus3Product Code
- MHRTest, Anti-Tumor Cell Susceptibility3Product Code
- MKTHepatitis Viral B Dna Detection3Product Code
- MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg3Product Code
- MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm3Product Code
- MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus3Product Code
- OIHYersinia Spp. ReagentsUProduct Code
- OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test3Product Code
- OJOEnzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of MycobacteriaNProduct Code
- ORLWhole Blood Pre-Treatment T-Cell Enrichment Reagent3Product Code
- OTTResearch Use Only/MicrobiologyNProduct Code
- OYBKit, Rna Detection, Human Papillomavirus3Product Code
- PABCytomegalovirus (Cmv) Dna Quantitative Assay3Product Code
- PCYInvestigational Use Only - MicrobiologyNProduct Code
- POAReagents, Zika Virus Nucleic AcidNProduct Code
- POGReagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic AcidNProduct Code
- PYSZika Virus Serological Reagents (Emergency Use)NProduct Code
- QHVMultiple Osteoarticular Pathogen Antigen KitNProduct Code
- QIMBartonella Spp. Serological ReagentsNProduct Code
- QINBabesia Spp. Serological ReagentsNProduct Code
- QIOAnaplasma Spp. And Ehrlichia Spp. Serological ReagentsNProduct Code
- QIPRickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological ReagentsNProduct Code
- QIQOrientia Spp. (Scrub Typhus) Serological ReagentsNProduct Code
- QJRReagents, 2019-Novel Coronavirus Nucleic AcidNProduct Code
- QKOReagent, Coronavirus SerologicalNProduct Code
- QKPCoronavirus Antigen Detection Test System.NProduct Code
- QLTCovid-19 Multi-Analyte Respiratory Panel Nucleic Acid DevicesNProduct Code
- QLWCovid-19 Test Home Collection Kit DevicesNProduct Code
- QMNCovid-19 Multi-Analyte Antigen DeviceNProduct Code
- QSHCoronavirus Marker DetectionNProduct Code
- QSNOrthopedic Infection Microbial Multiplex Nucleic Acid Detection System2Product Code
- QSSHiv Self-Tests3Product Code
- QTANgs Whole Genome Sequencing For Sars-Cov-2 Genetic AnalysisNProduct Code
- QTPReagents, Monkeypox Virus Nucleic Acid.NProduct Code
- QTQReagents, Non-Variola Orthopoxvirus Nucleic Acid.NProduct Code
- QWBOver-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens2Product Code
- QVRMultiplex Nucleic Acid Detection System For Biothreat Agents2Product Code
- QUUSimple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples2Product Code
- 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
- QXALateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection2Product Code
- 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
- QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing2Product Code
- 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
- SBZTest For Detection Of Antibodies Associated With Syphilis Performed By Lay Users2Product Code
- 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
- 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
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
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