Chemmette Reagents
Potassium Hydroxide (KOH 10%) Chemette
4manufacturers in China registered for this device type
2catalogue numbers in this listing
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 |
|---|---|---|
| 300195 | In distribution | |
| 300145 | 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 |
| Optochin | Oxoid, Ltd. | 2 |
| X Factor | Oxoid, Ltd. | 2 |
| X & V 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Microbiologics, Inc. | UDI-DI | 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.