Accustrip 10-Parameter Urine Reagent Strip
10-Parameter Urine Reagent Strip For Use with Accustrip URS Reader Blood, Urobilinogen, Billirubin, Protein, Nitrite, Ketone, Glucose, pH, SG, Leukocytes
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jilin (2), Guangxi (1). 2 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 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
| Shanghai Youding International Trade Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 17 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
Record
| Listed by | Jant Pharmacal Corp., United States |
|---|---|
| FDA product code | JRE |
| Device type | Refractometer For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2800 |
| Establishment | Complaint-file establishment |
| 510(k) | K991927 |
| Record published | 2016-09-24 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| UA870 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Teco Diagnostics | Teco Diagnostics | 5 |
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 2 |
| Accustrip URS Strips + Reader | Jant Pharmacal Corp. | 1 |
| PC | Allied Medical LLC | 1 |
| Urine Reagent Strips, 10-parameter | LW Scientific, Inc. | 1 |
| Reichert® Digital USG-Chek | Reichert Inc. | 1 |
| Detector UA 10 | Immunostics, Inc. | 1 |
| Clinical Refractometers Reichert® Digital Clinic-Chek | Reichert Inc. | 1 |
| Multistix® 9 Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| Accutest | Jant Pharmacal Corp. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Macherey-Nagel Gmbh & Co., KG. | 510(k) number | 2024-04-04 | Class II | Under Investigation by firm | The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potent | 5,200 packages |
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.