PEPFAST

GUDID 06979259840009

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

RD Biomed (Changsha) Limited

Pepsin IVD, kit, rapid ICT, clinical
Primary Device ID06979259840009
NIH Device Record Key11a29b15-f418-4823-8233-00a4223da4eb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEPFAST
Version Model NumberPEPF1
Company DUNS617582225
Company NameRD Biomed (Changsha) Limited
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+8651081819652
Emailpepfast@imaxhealth.com
Phone+8651081819652
Emailpepfast@imaxhealth.com
Phone+8651081819652
Emailpepfast@imaxhealth.com
Phone+8651081819652
Emailpepfast@imaxhealth.com
Phone+8651081819652
Emailpepfast@imaxhealth.com
Phone+8651081819652
Emailpepfast@imaxhealth.com
Phone+8651081819652
Emailpepfast@imaxhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106979259840009 [Primary]

FDA Product Code

JLLTubeless Analysis, Gastric Acidity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-31
Device Publish Date2025-12-23

On-Brand Devices [PEPFAST]

06979259840023Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pep
06979259840016Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pep
06979259840009Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pep

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