Primary Device ID | 07290012140600 |
NIH Device Record Key | c0510303-1cb9-4730-8f27-cd0313c6634e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | QwikCheck Beads Proficiency and Training Kit |
Version Model Number | QwikCheck Beads Proficiency and Training Kit |
Company DUNS | 514680529 |
Company Name | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 07290012140600 [Primary] |
NRF | Material, Quality Control, Semen Analysis |
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 |
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 |