Virotrol
VIROTROL Syphilis LR-B (An unassayed (human) serology control.)
2manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | OHQ |
| Device type | Multi-Analyte Controls Unassayed |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-14 |
| Record revised | 2023-01-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00172 | In distribution | |
| 00113X | In distribution | |
| 00132 | In distribution | |
| 00117A | In distribution | |
| 200305B | In distribution | |
| 200300C | In distribution | |
| 01400 | In distribution | |
| 00171 | In distribution | |
| 00117B | In distribution | |
| 200305C | In distribution | |
| 200305A | In distribution | |
| 12000538 | In distribution | |
| 00171X | In distribution | |
| 00128A | In distribution | |
| 00113 | In distribution | |
| 00143 | In distribution | |
| 00125 | In distribution | |
| 00142A | In distribution | |
| 00116 | In distribution | |
| 00172X | In distribution | |
| 00230 | In distribution | |
| 200300A | In distribution | |
| 00144 | In distribution | |
| 00128B | In distribution | |
| 200300B | In distribution | |
| 12000539 | In distribution | |
| 00125X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exact Diagnostics | Exact Diagnostics | 64 |
| NATtrol™ | Zeptometrix LLC. | 54 |
| QC Sets and Panels: Helix Elite™ | Microbiologics, Inc. | 51 |
| Helix Elite™ Molecular Standards: Inactivated Standard | Microbiologics, Inc. | 41 |
| Multichem S Plus | Techno-Path Manufacturing Ltd. | 35 |
| Helix Elite™ Molecular Standards: Synthetic Standard | Microbiologics, Inc. | 25 |
| Multichem IA Plus | Techno-Path Manufacturing Ltd. | 17 |
| D3 | Diagnostic Hybrids, Inc. | 14 |
| Liquichek | Bio-Rad Laboratories Inc. | 10 |
| Multichem IA | Techno-Path Manufacturing Ltd. | 8 |
| QC Sets and Panels: Kwik-Stik™ 2 Pack | Microbiologics, Inc. | 8 |
| QC Sets and Panels: Kwik-Stik™ | Microbiologics, Inc. | 7 |
Showing 12 of 107. All products under Multi-Analyte Controls Unassayed
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.