Remel
Xpect C. diff Toxin A/B KT/40TST
1manufacturer
2catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
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 | Remel, Inc., United States |
|---|---|
| FDA product code | LLH |
| Device type | Reagents, Clostridium Difficile Toxin |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K041951 |
| Record published | 2022-04-21 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R24640 | 40 | In distribution | |
| R24650 | 20 | 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 |
| Xpert C. difficile | Cepheid | 2 |
| Trinity Biotech | Mardx Diagnostics, Inc. | 2 |
| TOX A/B Quik Chek | Techlab, 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 |
|---|---|
| K041951 | 2004-11-15 |
| K033479 | 2004-02-26 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2012-08-20 | Class II | Material/Component Contamination | The firm is recalling the products due to a potential for false negative test results. | 50 units | 2013-06-04 |
| 2012-08-20 | Class II | Material/Component Contamination | The firm is recalling the products due to a potential for false negative test results. | 493 of lot 082505; 529 of lot 131988; and 448 of lot 131994 | 2013-06-04 |
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.