NanoVIP®
Catalogue number AS1020, listed by Biogenex Laboratories Inc., United States, under Stainer, Tissue, Automated. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2recalls on this code
Who Else Makes It
Registered in Hubei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
Record
| Listed by | Biogenex Laboratories Inc., United States |
|---|---|
| FDA product code | KEY |
| Device type | Stainer, Tissue, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS1020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VP2000 | Abbott Molecular, Inc. | 10 |
| Millennium | Avalign Technologies, Inc. | 2 |
| i6000™ Infinity | Biogenex Laboratories Inc. | 1 |
| Xmatrx® Infinity | Biogenex Laboratories Inc. | 1 |
| Xmatrx® Elite | Biogenex Laboratories Inc. | 1 |
| i6000™ Diagnostics | Biogenex Laboratories Inc. | 1 |
| Xmatrx® Nano | Biogenex Laboratories Inc. | 1 |
| Xmatrx® Mini | Biogenex Laboratories Inc. | 1 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-01-23 | Not classified | Device Design | Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution. | 12 units | 2010-12-02 |
| 2008-01-24 | Not classified | Component design/selection | Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals. | 10 units distributed. | 2011-01-08 |
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.