← FDA Medical Device Classifications
Reagent Red Blood Cells
QHT · Unclassified · Hematology · 21 CFR 660.30
Classification
- FDA Product Code
QHT- Device class
- Unclassified
- Regulation
- 21 CFR 660.30
- Review panel
- HE
- Medical specialty
- Hematology
- Submission type
- 3
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For the detection of or identification of human blood-group antibodies
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown