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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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Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
- Page Type
- Product Code
- Definition
- The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
- Physical State
- In vitro diagnostic device
- Technical Method
- Qualitative DNA amplification technology
- Target Area
- Human clinical specimens
- Regulation Medical Specialty
- Microbiology
- Review Panel
- Microbiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.3181
- 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 QDZ is linked to regulation 21CFR866.3181, which does not seem to exist yet. It may be pending at the moment.