Serim® PeriScreen™ Test Strips
Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.
16manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (6), Zhejiang (5), Guangxi (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 |
| Jiangsu Medomics Medical Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 5 |
| 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 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
Showing 12 of 16. All 16 manufacturers in China registered for Test, Urine Leukocyte
Record
| Listed by | Serim Research Corp., United States |
|---|---|
| FDA product code | LJX |
| Device type | Test, Urine Leukocyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.7675 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K000578 |
| Record published | 2016-09-08 |
| Record revised | 2026-02-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Handling environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5122 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exploro Urinary Tract Infection (UTI) Test | Safecare Biotech(Hangzhou)Co., Ltd. | 6 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Teco Diagnostics | Teco Diagnostics | 3 |
| Moore Medical | Moore Medical Corp. | 2 |
| Alltest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2 |
| Welcheck Urinary Tract Infection Test | Safecare Biotech(Hangzhou)Co., Ltd. | 2 |
| T Testahead Urinary Tract Infection Test | Safecare Biotech(Hangzhou)Co., Ltd. | 2 |
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 2 |
| Hema-Combistix® Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| urinalysis strips | Weihai Kangzheng Medical Equipment Technology Co., Ltd. | 1 |
| One+Step 10A | DFI Co., Ltd. | 1 |
| Mission Urinary Tract Infection (UTI) Test strips | Acon Laboratories, Inc. | 1 |
Showing 12 of 29. All products under Test, Urine Leukocyte
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K000578 | 2000-05-05 |
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.