← FDA Medical Device Classifications
Anti-Human Globulin
QHS · Unclassified · Hematology · 21 CFR 660.50
Classification
- FDA Product Code
QHS- Device class
- Unclassified
- Regulation
- 21 CFR 660.50
- Review panel
- HE
- Medical specialty
- Hematology
- Submission type
- 3
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown