← FDA Medical Device Classifications
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
QDZ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3181
Classification
- FDA Product Code
QDZ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.3181
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown