Diastix®
Reagent strips for urinalysis - glucose. 100 test strips.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Ascensia Diabetes Care US Inc., United States |
|---|---|
| FDA product code | JIL |
| Device type | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1340 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K831600 |
| Record published | 2016-09-16 |
| Record revised | 2024-11-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Use within 6 mont; Storage environment temperature 59 to 86 °F |
| Packaging | Carton, shipper/case of 12, shipper/case of 24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2803 | 100 | In distribution | |
| 2806 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Teco Diagnostics | Teco Diagnostics | 19 |
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 11 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Henry Schein | Henry Schein, Inc. | 5 |
| Keto-Diastix® | Ascensia Diabetes Care US Inc. | 2 |
| Chemstrip 9 Urine Test Strips | Roche Diagnostics Gmbh | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Aution MAX™ AX-4060 Analyzer | Arkray USA, Inc. | 2 |
| Aimstrip US-3 | Germaine Laboratories, Inc. | 1 |
| Urine Strips | Urit Medical Electronic Co., Ltd. | 1 |
| Chemstrip 10 MD Test Strips | Roche Diagnostics Gmbh | 1 |
| Urine Reagent Strips, 2-parameter; glucose, protein | LW Scientific, Inc. | 1 |
Showing 12 of 34. All products under Method, Enzymatic, Glucose (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.