← FDA Medical Device Classifications
Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
SDN · Unclassified · Unknown
Classification
- FDA Product Code
SDN- Device class
- Unclassified
- Regulation
- —
- Review panel
- MI
- Medical specialty
- Unknown
- 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 cadaveric (non-heart-beating) specimens
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown