Mission Urinalysis Reagent Strips
Mission Urinalysis Reagent Strips (GLU/SG/BLO/PH/PRO/URO/NIT/LEU)
16manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Acon Laboratories, Inc., United States |
|---|---|
| FDA product code | LJX |
| Device type | Test, Urine Leukocyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.7675 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2025-06-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 36 to 86 °F; Special storage condition: Keep out of direct sunlight; Special storage condition: Store in a cool, dry place |
| Packaging | Carton of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| U031-081 | 100 | In distribution | |
| U031-031 | 100 | 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 |
| 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 |
| Aimstrip US-11 | Germaine Laboratories, Inc. | 1 |
Showing 12 of 29. All products under Test, Urine Leukocyte
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063295 | 2007-10-12 |
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.