PEPFAST

Basic Information

• Brand Name: PEPFAST
• Primary DI: 06979259840023
• Version / Model: PEPF50
• Company Name: RD Biomed (Changsha) Limited
• Labeler DUNS: 617582225
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-23
• Public Version: 1
• Public Version Date: 2025-12-31
• Public Version Status: New
• Public Device Record Key: fad32518-9303-40a1-a9ab-d63b7a5df327

Device Description

Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pepsin in human saliva.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JLL	Tubeless Analysis, Gastric Acidity	Clinical Chemistry	862.1320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63092	Pepsin IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of pepsin in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06979259840023	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]