Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- OYMProstrate Cancer Genes Nucleic Acid Amplification Test System3Product Code
- KTJSystem, Test, Alpha-Fetoprotein, Ria3Product Code
- LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects3Product Code
- LTQCalibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum3Product Code
- MANAssay, Interleukin3Product Code
- MJBAntigen, Cancer 5493Product Code
- MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer3Product Code
- MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions3Product Code
- MYZKit, Test (Donors), For Bloodborne Pathogen2Product Code
- MZATest, Equipment, Automated Bloodborne PathogenNProduct Code
- MZETest, Donor, Cmv2Product Code
- MZFTest, Hiv Detection3Product Code
- MZLKit, Test, Quality Control For EndotoxinNProduct Code
- NAFAntigen(Complexed),Prostate Specific,(Cpsa)3Product Code
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer3Product Code
- NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer3Product Code
- OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic MesotheliomaFProduct Code
- OCBRt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection3Product Code
- OTRResearch Use Only/Immunology DevicesNProduct Code
- OWDSomatic Gene Mutation Detection System3Product Code
- OYAP2psa3Product Code
- OYYLeukemia Translocation Panel Multiplex TestNProduct Code
- PILTest For Periprosthetic Joint InfectionNProduct Code
- QLCInterleukin 6NProduct Code
- QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer3Product Code
- QSEAlzheimer’S Disease Pathology Assessment Test2Product Code
- QWQAssays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors3Product Code
- SADJapanese Encephalitis Virus Immunological/Serology TestNProduct Code
- SETImmunoassay Blood Test For Amyloid Pathology Assessment2Product Code
- SFCNeurologic Disease Risk Assessment Molecular Test2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
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Neurologic Disease Risk Assessment Molecular Test
- Page Type
- Product Code
- Definition
- A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information.
- Physical State
- Molecular test system used to detect variants in RNA or genomic DNA from human specimens. System accessory includes collection device for the human specimen.
- Technical Method
- Next Generation Sequencing, Microarray, and Real-Time PCR.
- Target Area
- Human specimens, excluding home collected specimens.
- Regulation Medical Specialty
- Immunology
- Review Panel
- Immunology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.5850
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code SFC is linked to regulation 21CFR866.5850, which does not seem to exist yet. It may be pending at the moment.