Mission Urinalysis Reagent Strips
Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)
5manufacturers in China registered for this device type
10catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Jilin (1), Guangxi (1). 3 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 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Record
| Listed by | Acon Laboratories, Inc., United States |
|---|---|
| FDA product code | JIO |
| Device type | Blood, Occult, Colorimetric, In Urine |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2025-06-20 (version 8) |
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: Store in a cool, dry place; Special storage condition: Keep out of direct sunlight |
| Packaging | Carton of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| U031-021 | 100 | In distribution | |
| U031-041 | 100 | In distribution | |
| U031-051 | 100 | In distribution | |
| U031-011 | 100 | In distribution | |
| U031-021 | 100 | In distribution | |
| U031-071 | 100 | In distribution | |
| U031-051 | 100 | In distribution | |
| U031-031 | 100 | In distribution | |
| U031-061 | 100 | In distribution | |
| U031-011 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Teco Diagnostics | Teco Diagnostics | 6 |
| Detector UA 5 | Immunostics, Inc. | 1 |
| Clinitek Advantus® Analyzer | Siemens Healthcare Diagnostics Inc | 1 |
| Urisys 2400 Cassette | Roche Diagnostics Gmbh | 1 |
| Urisys 2400 Calibration strip | Roche Diagnostics Gmbh | 1 |
| Aimstrip US-4 | Germaine Laboratories, Inc. | 1 |
| Urine Reagent Strips, 5-parameter | LW Scientific, Inc. | 1 |
| Labstix® Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Blood, Occult, Colorimetric, In Urine | Remel, Inc. | 1 |
| McKesson | Mckesson Medical-Surgical Inc. | 1 |
| Urine Chemistry Strips | Urit Medical Electronic Co., Ltd. | 1 |
| Mission U120 Smart Urine Analyzer | Acon Laboratories, Inc. | 1 |
Showing 12 of 17. All products under Blood, Occult, Colorimetric, In Urine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111221 | 2012-01-18 |
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.