Xpert C. Difficile
Xpert C. difficile test; 120 test kit
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
Record
| Listed by | Cepheid, United States |
|---|---|
| FDA product code | LLH |
| Device type | Reagents, Clostridium Difficile Toxin |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K091109 |
| Record published | 2018-01-29 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 28 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GXCDIFFICILE-120 | In distribution | |
| GXCDIFFICILE-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| C. Diff Quik Chek Complete | Techlab, Inc. | 5 |
| C. Diff Chek – 60 | Techlab, Inc. | 5 |
| C. Difficile TOX A/B II | Techlab, Inc. | 5 |
| Trinity Biotech | Mardx Diagnostics, Inc. | 2 |
| TOX A/B Quik Chek | Techlab, Inc. | 2 |
| Remel | Remel, Inc. | 2 |
| C. Difficile TOX-B Test | Techlab, Inc. | 2 |
| Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 2 |
| Vidas® C. difficile Toxin A & B | bioMerieux, Inc. | 1 |
| ProSpecT™ Wash Buffer | Oxoid, Ltd. | 1 |
| Chorus Clia Clostridium Difficile A/B Toxins | Diesse Diagnostica Senese SPA | 1 |
| Prodesse | Hologic, Inc. | 1 |
Showing 12 of 16. All products under Reagents, Clostridium Difficile Toxin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091109 | 2009-07-09 |
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.