FDA.reportPublic FDA data

PEPFAST

Primary DI
06979259840016
Brand
PEPFAST
Company
RD Biomed (Changsha) Limited
Model
PEPF10
Device description
Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pepsin in human saliva.
Published
2025-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JLLTubeless Analysis, Gastric Acidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLLTubeless Analysis, Gastric AcidityClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979259840016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979259840016069792598400166979259840016

GMDN Terms#

Term, Definition table
TermDefinition
Pepsin IVD, kit, rapid ICT, clinicalA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8651081819652pepfast@imaxhealth.com

Regulatory Flags#

DUNS number
617582225
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979259840009PEPFASTPEPF12025-12-23
06979259840023PEPFASTPEPF502025-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979259840009PEPFASTRD Biomed (Changsha) LimitedJLL2025-12-23
06979259840023PEPFASTRD Biomed (Changsha) LimitedJLL2025-12-23
05060590880401EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880432EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880692EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880746EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
00861145002607RightSpotpH®RIGHTBIO/METRICS INC.JLL2018-11-10
40861145002605RightSpotpH®RIGHTBIO/METRICS INC.JLL2018-11-10
00709078006050FeedSafeWESTMED, INC.JLL2018-09-25
00709078006067FeedSafeWESTMED, INC.JLL2018-09-25
10709078006057FeedSafeWESTMED, INC.JLL2018-09-25
10709078006064FeedSafeWESTMED, INC.JLL2018-09-25