Just Fitter Ph Test Strips
Catalogue number 31KC, listed by DFI Co., Ltd., South Korea, under Dye-Indicator, Ph (Urinary, Non-Quantitative). 16 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (5), Jilin (5), Jiangsu (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Guangdong Kawada Sanitary Products Co., Ltd. Southern District Branch Company. | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
Showing 12 of 16. All 16 manufacturers in China registered for Dye-Indicator, Ph (Urinary, Non-Quantitative)
Record
| Listed by | DFI Co., Ltd., South Korea |
|---|---|
| FDA product code | CEN |
| Device type | Dye-Indicator, Ph (Urinary, Non-Quantitative) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1550 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-25 |
| Record revised | 2022-11-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31KC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 7 |
| Teco Diagnostics | Teco Diagnostics | 7 |
| Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | 2 |
| Ezy Dose | Apothecary Products, LLC. | 2 |
| GoldN Easy to Use Vaginal pH Test | Novodx Corporation | 1 |
| Feminine Screening Kit | Peptonic Medical Israel Ltd | 1 |
| Feminine Screening Kit | Savyon Diagnostics Ltd. | 1 |
| One+Step pH | DFI Co., Ltd. | 1 |
| Vagi-Screen Vaginal Health Test | Peptonic Medical Israel Ltd | 1 |
| VagiVital VS | Peptonic Medical Israel Ltd | 1 |
| Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry | Siemens Healthcare Diagnostics Inc | 1 |
| Equate | Peptonic Medical Israel Ltd | 1 |
Showing 12 of 29. All products under Dye-Indicator, Ph (Urinary, Non-Quantitative)
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-04-02 | Class II | No Marketing Application | The devices were distributed without required FDA premarket clearance or approval. | 7860 units |
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.