Multistix PRO® 10LS Reagent Strips
Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone…
Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.
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 | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | CEN |
| Device type | Dye-Indicator, Ph (Urinary, Non-Quantitative) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1550 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K992257 |
| Record published | 2016-09-24 |
| Record revised | 2022-11-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not store in direct sunlight.; Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10331147 | 100 | 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 |
| Just Fitter pH Test Strips | DFI Co., Ltd. | 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 |
Showing 12 of 29. All products under Dye-Indicator, Ph (Urinary, Non-Quantitative)
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.