Henry Schein
Urispec Pro 5OB Urine Strip
5manufacturers in China registered for this device type
5catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | JIL |
| Device type | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1340 |
| Record published | 2019-05-24 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C |
| Packaging | Pack of 24, pack of 12 |
| Sizes | Height 7.5 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5701310 | Height 7.5 cm | In distribution |
| 9004995 | In distribution | |
| 5701308 | Height 7.5 cm | In distribution |
| 9004996 | In distribution | |
| 1006567 | 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 |
| 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 |
| 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.