← FDA Medical Device Classifications
Reagent, Coronavirus Serological
QKO · Not classified · Unknown
Classification
- FDA Product Code
QKO- Device class
- Not classified
- Regulation
- —
- Review panel
- MI
- Medical specialty
- Unknown
- Submission type
- 8
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 59
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown