General Purpose Reagent Delayed Semen Analysis Media

GUDID 00868586000285

DSAM Delayed Semen Analysis Media (Preservative media 150 µl) For Laboratory Use Only. INTENDED USE: The Delayed Semen Analysis Media (DSAM) is intended to be used at the direction of a health care professional for a patient to collect their own semen specimen for testing by a clinical laboratory.

Quest Diagnostics

Home semen collection kit IVD
Primary Device ID00868586000285
NIH Device Record Key50e1b68e-1acb-48f5-a772-f3b6ec3ccd47
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeneral Purpose Reagent Delayed Semen Analysis Media
Version Model NumberPPM
Company DUNS189222334
Company NameQuest Diagnostics
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
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
GS100868586000285 [Primary]

FDA Product Code

PPMGeneral Purpose Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-19
Device Publish Date2023-07-11

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00868586000285 - General Purpose Reagent Delayed Semen Analysis Media2023-07-19DSAM Delayed Semen Analysis Media (Preservative media 150 µl) For Laboratory Use Only. INTENDED USE: The Delayed Semen Analysis Media (DSAM) is intended to be used at the direction of a health care professional for a patient to collect their own semen specimen for testing by a clinical laboratory.
00868586000285 - General Purpose Reagent Delayed Semen Analysis Media2023-07-19 DSAM Delayed Semen Analysis Media (Preservative media 150 µl) For Laboratory Use Only. INTENDED USE: The Delayed Semen Analys

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