X Factor
2 catalogue numbers from DD0003T, listed by Oxoid, Ltd., United Kingdom, under Discs, Strips And Reagents, Microorganism Differentiation. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Oxoid, Ltd., United Kingdom |
|---|---|
| FDA product code | JTO |
| Device type | Discs, Strips And Reagents, Microorganism Differentiation |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K802500 |
| Record published | 2022-12-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DD0003T | In distribution | |
| DD0003B | 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 & V Factor | Oxoid, Ltd. | 2 |
Showing 12 of 139. All products under Discs, Strips And Reagents, Microorganism Differentiation
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.