General Purpose Reagent Delayed Semen Analysis Media

Basic Information

• Brand Name: General Purpose Reagent Delayed Semen Analysis Media
• Primary DI: 00868586000285
• Version / Model: PPM
• Company Name: Quest Diagnostics
• Labeler DUNS: 189222334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-11
• Public Version: 2
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: 50e1b68e-1acb-48f5-a772-f3b6ec3ccd47

Device Description

Delayed Semen Analysis Collection Cup and Pipette

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66354	Home semen collection kit IVD	A collection of in vitro diagnostic devices and materials intended to be used by a layperson in the home to collect a semen specimen for subsequent in vitro diagnostic investigations (e.g., fertility testing). The kit typically includes a covered specimen receptacle with a preservative, a pipette, instructions for use, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868586000285	GS1