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Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
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
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown