Tanner Scientific®
Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase
16manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (6), Zhejiang (5), Guangxi (1). 5 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 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Jiangsu Medomics Medical Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Safecare Biotech(Hangzhou)Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 22 |
Showing 12 of 16. All 16 manufacturers in China registered for Test, Urine Leukocyte
Record
| Listed by | Mercedes Medical LLC, United States |
|---|---|
| FDA product code | LJX |
| Device type | Test, Urine Leukocyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.7675 |
| Establishment | Complaint-file establishment |
| 510(k) | K111999 |
| Record published | 2016-08-15 |
| Record revised | 2025-11-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Strips must be kept in the original bottle, or it may shorten the expiration date of product.; Special storage condition: Do not remove desiccants in the bottles.; Special storage condition: Keep away from direct sunlight, and moisture.; Handling environment temperature 39 to 86 °F |
| Packaging | Inner pack of 100, case |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TNR 10SG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exploro Urinary Tract Infection (UTI) Test | Safecare Biotech(Hangzhou)Co., Ltd. | 6 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Teco Diagnostics | Teco Diagnostics | 3 |
| Moore Medical | Moore Medical Corp. | 2 |
| Alltest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2 |
| Welcheck Urinary Tract Infection Test | Safecare Biotech(Hangzhou)Co., Ltd. | 2 |
| T Testahead Urinary Tract Infection Test | Safecare Biotech(Hangzhou)Co., Ltd. | 2 |
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 2 |
| Hema-Combistix® Reagent Strips | Siemens Healthcare Diagnostics Inc | 1 |
| urinalysis strips | Weihai Kangzheng Medical Equipment Technology Co., Ltd. | 1 |
| One+Step 10A | DFI Co., Ltd. | 1 |
| Mission Urinary Tract Infection (UTI) Test strips | Acon Laboratories, Inc. | 1 |
Showing 12 of 29. All products under Test, Urine Leukocyte
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 |
|---|---|---|---|---|---|---|
| Healgen Scientific LLC | 510(k) number | 2024-08-22 | Class II | Nonconforming Material/Component | The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color f | 1,636,994 Tests |
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.