General Reagents
Potassium Hydroxide (KOH 10%) 50mL
4manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Jilin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
| Zhejiang Joozena Medical Technology Co., Ltd. | Dongyang City, Jinhua | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Microbiologics, Inc., United States |
|---|---|
| FDA product code | JTO |
| Device type | Discs, Strips And Reagents, Microorganism Differentiation |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-26 |
| Record revised | 2024-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60015 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 62 |
| Discs, Strips And Reagents, Microorganism Differentiation | Hardy Diagnostics | 37 |
| HardyDisk™ | Hardy Diagnostics | 17 |
| Bactidrop | Remel, Inc. | 10 |
| Redipor | Analytichem USA, Inc. | 7 |
| BD BBL™ Taxo™ P | Becton, Dickinson AND Company | 4 |
| BD BBL™ Taxo™ A | Becton, Dickinson AND Company | 4 |
| API® NaCl 0.85% Medium | bioMerieux, Inc. | 3 |
| Bacticard | Remel, Inc. | 3 |
| Chemmette Reagents | Microbiologics, Inc. | 2 |
| Optochin | Oxoid, Ltd. | 2 |
| X Factor | Oxoid, Ltd. | 2 |
Showing 12 of 139. All products under Discs, Strips And Reagents, Microorganism Differentiation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970009 | 1997-02-06 |
| K954812 | 1995-12-20 |
| K951889 | 1995-08-24 |
| K945883 | 1995-04-24 |
| K945881 | 1995-04-24 |
| K945882 | 1995-04-24 |
| K945880 | 1995-04-24 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-07-01 | Class II | Mixed-up of materials/components | A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%. | 11 kits | 2023-05-02 |
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.