CMV Probe ASR
The CMV Probe ASR contains a specific nucleic acid sequence for detection of Cytomegalovirus (CMV). The CMV Probe ASR is designed to detect a region of the MIE gene in the CMV genome. The…
The CMV Probe ASR contains a specific nucleic acid sequence for detection of Cytomegalovirus (CMV). The CMV Probe ASR is designed to detect a region of the MIE gene in the CMV genome. The DNA is synthetically derived. Analyte Specific Reagent. Analytical and performance characteristics are not established.
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 | Qiagen, Gmbh, Germany |
|---|---|
| FDA product code | MVU |
| Device type | Reagents, Specific, Analyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4020 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-06-02 |
| Record revised | 2025-08-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -30 to -15 °C; Special storage condition: Store in constant temperature freezer. |
| Distribution end date | 2025-08-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V1 | Withdrawn |
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.