← FDA Medical Device Classifications
Manual Blood Grouping And Antibody Test Systems
PBC · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.9175
Classification
- FDA Product Code
PBC- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 864.9175
- Review panel
- HE
- Medical specialty
- Hematology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 4
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown