| Primary Device ID | 07290016650617 |
| NIH Device Record Key | 0c972e4f-3f1e-431f-b489-6476abb53d47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QwikCheck DFI Kit |
| Version Model Number | QwikCheck DFI Kit: 10 Tests |
| Company DUNS | 514680529 |
| Company Name | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016650617 [Primary] |
| IAF | Wright'S Stain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
| 07290016650402 - SQA-iO Sperm Quality Analyzer | 2023-09-14 |
| 07290012140136 - QwikCheck Beads | 2023-06-16 |
| 07290012140143 - QwikCheck Dilution Kit | 2023-06-16 |
| 07290012140150 - QwikCheck Liquefaction | 2023-06-16 |
| 07290012140600 - QwikCheck Beads Proficiency and Training Kit | 2023-06-16 |
| 07290012140891 - QwikCheck Vitality Kit | 2023-06-16 |
| 07290016650020 - QwikCheck Beads Precision and Linearity kit | 2023-06-16 |
| 07290016650617 - QwikCheck DFI Kit | 2023-06-16 |
| 07290016650617 - QwikCheck DFI Kit | 2023-06-16 |