← FDA Medical Device Classifications
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
NWY · Not classified · Unknown
Classification
- FDA Product Code
NWY- Device class
- Not classified
- Regulation
- —
- Review panel
- MI
- Medical specialty
- Unknown
- Submission type
- 3
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown