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