← FDA Medical Device Classifications
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
QHM · Unclassified · Microbiology · 21 CFR 610.40
Classification
- FDA Product Code
QHM- 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 antibodies or antigens to 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