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- PVQRickettsia Spp. Nucleic Acid Based Detection Assay2Product Code
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- QIDDevice To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens2Product Code
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- 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
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- 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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- QYTOver-The-Counter Covid-19 Antigen Test2Product 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
- SEATest For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users2Product Code
- SEPDevice For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay2Product Code
- SGABiothreat Microbial Agent Nucleic Acid Detection Test2Product Code
- QTUReagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen TestsNProduct 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
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Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- Page Type
- Product Code
- Definition
- A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for testing using an approved HPV molecular assay.
- Physical State
- A device consisting of components for vaginal specimens self-collection and transport.
- Technical Method
- Lay user uses a device to self-collect and transport vaginal specimens for laboratory testing using an approved HPV molecular assay.
- Target Area
- Vagina.
- Regulation Medical Specialty
- Microbiology
- Review Panel
- Microbiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.2920
- 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 SEP is linked to regulation 21CFR866.2920, which does not seem to exist yet. It may be pending at the moment.