MicroVue
Kit, Quidel Bb Plus
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Quidel Corp., United States |
|---|---|
| FDA product code | JZH |
| Device type | Factor B, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5320 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2023-06-29 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Bp Plus EIA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Immage | Beckman Coulter, Inc. | 1 |
| Anti Human C-3 Proactivator (Factor B) | Kent Laboratories, Inc. | 1 |
| Anti Human Complement C-3 Proactivator Fitc | Kent Laboratories, Inc. | 1 |
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.