QwikCheck Beads Proficiency and Training Kit

GUDID 07290012140600

M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Sperm energy status and motility testing reagent IVD
Primary Device ID07290012140600
NIH Device Record Keyc0510303-1cb9-4730-8f27-cd0313c6634e
Commercial Distribution StatusIn Commercial Distribution
Brand NameQwikCheck Beads Proficiency and Training Kit
Version Model NumberQwikCheck Beads Proficiency and Training Kit
Company DUNS514680529
Company NameM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290012140600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRFMaterial, Quality Control, Semen Analysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

Devices Manufactured by M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

07290016650402 - SQA-iO Sperm Quality Analyzer2023-09-14
07290012140136 - QwikCheck Beads2023-06-16
07290012140143 - QwikCheck Dilution Kit2023-06-16
07290012140150 - QwikCheck Liquefaction2023-06-16
07290012140600 - QwikCheck Beads Proficiency and Training Kit2023-06-16
07290012140600 - QwikCheck Beads Proficiency and Training Kit2023-06-16
07290012140891 - QwikCheck Vitality Kit2023-06-16
07290016650020 - QwikCheck Beads Precision and Linearity kit2023-06-16
07290016650617 - QwikCheck DFI Kit2023-06-16

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