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

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• Primary Device ID: 00868586000285
• NIH Device Record Key: 50e1b68e-1acb-48f5-a772-f3b6ec3ccd47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Purpose Reagent Delayed Semen Analysis Media
• Version Model Number: PPM
• Company DUNS: 189222334
• Company Name: Quest Diagnostics
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00868586000285 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-19
• Device Publish Date: 2023-07-11

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• 00868586000285 - General Purpose Reagent Delayed Semen Analysis Media: 2023-07-19DSAM 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 Media: 2023-07-19 DSAM Delayed Semen Analysis Media (Preservative media 150 µl) For Laboratory Use Only. INTENDED USE: The Delayed Semen Analys