InstaTest
Diagnostic Automation Inc. URS-2P (100 Strips Bottle) for the semi-quantitative and qualitative detection of Glucose and Protein in Urine.
5manufacturers in China registered for this device type
1catalogue number
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 | Diagnostic Automation, Inc. |
|---|---|
| FDA product code | JIL |
| Device type | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1340 |
| Record published | 2021-09-23 |
| Record revised | 2022-11-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| URS-2P (100) | 100 Strips/ Bottle | 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 |
| Diastix® | Ascensia Diabetes Care US 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 |
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.