Pepfast
Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pepsin in human saliva.
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Hunan.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| RD Biomed (Changsha) Ltd. | Changsha | Hunan | Manufacturer | 1 |
Record
| Listed by | RD Biomed (Changsha) Ltd., China |
|---|---|
| FDA product code | JLL |
| Device type | Tubeless Analysis, Gastric Acidity |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1320 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PEPF10 | In distribution | |
| PEPF1 | In distribution | |
| PEPF50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enteral | Gbuk Group Limited | 4 |
| FeedSafe | Westmed, Inc. | 2 |
| RightSpotpH® | Rightbio/Metrics Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.