Norovirus Serological Reagent
Device Code: 3539
Product Code(s):
OUC Definition: Norovirus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Detection Of Anti-norovirus Antibodies Or Norovirus Antigens. The Detection Aids In The Clinical Laboratory Diagnosis Of Norovirus Infection In Individuals With
Device Classification Information
| Device Type ID | 3539 |
| Device Name | Norovirus Serological Reagent |
| Physical State | Laboratory Kit. |
| Technical Method | ELISA-based Or Immunological Based Assays. |
| Target Area | Human Biological Specimens. |
| Regulation Description | Norovirus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.3395 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3539 |
| Device | Norovirus Serological Reagent |
| Product Code | OUC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Norovirus Serological Reagents. |
| CFR Regulation Number | 866.3395 [🔎] |
TPLC Last Update: 2019-04-02 20:31:59