Material, Quality Control, Semen Analysis
Device Code: 2428
Product Code(s):
NRF Definition: A Semen Analysis Quality Control Material Is A Device Used To Determine The Accuracy And Precision Of Manual, Semiautomated, And Automated Determinations Of Semen Analysis Parameters Such As PH, Sperm Concentration, Total Sperm Number, Motility, Morp
Device Classification Information
| Device Type ID | 2428 |
| Device Name | Material, Quality Control, Semen Analysis |
| Regulation Description | Hematology Quality Control Mixture. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.8625 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NRF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 2428 |
| Device | Material, Quality Control, Semen Analysis |
| Product Code | NRF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hematology Quality Control Mixture. |
| CFR Regulation Number | 864.8625 [🔎] |
TPLC Last Update: 2019-04-02 20:11:51