Definition: The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (CMV) DNA In Saliva From Newborn Babies.
| Device Type ID | 3594 |
| Device Name | Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Qualitative DNA Amplification Technology |
| Target Area | Human Clinical Specimens |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3181 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3594 |
| Device | Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection |
| Product Code | QDZ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3181 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MERIDIAN BIOSCIENCE, INC. | ||
GRANTED | 1 | |
MERIDIAN CO., LTD. | ||
GRANTED | 1 | |