Men's Rapid Fertility Test

GUDID 00862105000305

Men's Rapid Fertility Test, 2-Test Kit

MEDTOX DIAGNOSTICS, INC.

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Primary Device ID00862105000305
NIH Device Record Keya661547b-b3ca-4b6b-aa94-dfeb40a212fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMen's Rapid Fertility Test
Version Model NumberTTK-0-3 Rev 4
Company DUNS118569262
Company NameMEDTOX DIAGNOSTICS, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100862105000305 [Primary]

FDA Product Code

POVSemen Analysis Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-13