Bond™
HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA in formalin-fixed, paraffin-embedded tissue by in…
HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). This probe binds to the five high risk HPV subtypes, 16, 18, 31, 33 and 51.
Who Else Makes It
Concentrated in Guangdong (2), Hunan (1), Henan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Henan Celnovte Biotechnology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 8 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
| Shenzhen Dartmon Biotechnology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shanghai ZJ BIO-Tech Co., Ltd. | Shanghai | Shanghai | Private-label distributor | 3 |
| Diaglogic Biolabs (Xiamen) Co., Ltd. | Xiamen | Fujian | Manufacturer | 1 |
Record
| Listed by | Leica Biosystems Newcastle Ltd, United Kingdom |
|---|---|
| FDA product code | MVU |
| Device type | Reagents, Specific, Analyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4020 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PB0682 | In distribution | |
| PB0785 | In distribution | |
| PB0809 | In distribution | |
| PB0731 | In distribution | |
| PB0614 | In distribution | |
| PB0589 | In distribution | |
| PB0829 | In distribution | |
| PB0780 | In distribution | |
| PB0645 | In distribution | |
| PB0669 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CytoCell myProbes | Cytocell Limited | 1,286 |
| Beckmancoulter | Immunotech Corp. | 678 |
| CytoCell | Cytocell Limited | 587 |
| MetaSystems Probes | Metasystems Probes Gmbh | 529 |
| Reagents, Specific, Analyte | Becton, Dickinson AND Company | 288 |
| Vysis | Abbott Molecular, Inc. | 248 |
| Kreatech Fish probes | Leica Biosystems Newcastle Ltd | 197 |
| Horizon | Becton, Dickinson AND Company | 145 |
| goldFISH | Lumatas Biosystems, Inc | 119 |
| Immunalysis | Immunalysis Corporation | 97 |
| Invivoscribe | Invivoscribe, Inc. | 91 |
| Fort Worth Diagnostics | Fort Worth Diagnostics LLC | 88 |
Showing 12 of 3,073. All products under Reagents, Specific, Analyte
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.