# Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
> **Product code: QHO** · Unclassified · Microbiology · 21 CFR 610.40
## Classification
- **FDA Product Code:** QHO
- **Device class:** Unclassified
- **Regulation:** 21 CFR 610.40
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 3
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

For the qualitative detection of nucleic acid for infectious disease agents in human specimens.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QHO)
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