RealStar® MERS-CoV RT-PCR Kit U.S.*
The RealStar® MERS-CoV RT-PCR Kit U.S.* is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA from Middle East respiratory syndrome coronavirus (MERS-CoV).
*Only available in USA. For use under the Emergency Use Authorization (EUA) only.
Sample types
- In lower respiratory samples (tracheal aspirate / tracheal secretions) from patients with signs and symptoms of Middle East respiratory syndrome coronavirus infection in conjunction with epidemiological risk factors
- In nasopharyngeal swabs from asymptomatic individuals suspected of exposure to MERS-CoV cases based on epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated)
Please remark:
- This test has not been FDA-cleared or approved;
- This test has been authorized by FDA under an EUA for use by CLIA high complexity laboratories and similarly qualified non-U.S. laboratories;
- This test has been authorized only for the detection of MERS-CoV; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of MERS-CoV under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
RealStar® MERS-CoV RT-PCR Kit U.S.*
| Order No. | 391022 |
| Rxns | 48 |
| Sample types | Lower respiratory samples (tracheal aspirate / tracheal secretions) Nasopharyngeal swabs |
| Transportation | Dry ice |
| For use with | VERSANT® kPCR Molecular System AD ABI Prism® 7500 SDS and 7500 Fast SDS LightCycler® 480 Instrument II Roto-Gene® 6000 Rotor-Gene® Q 5/6 plex Platfom CFX96™ Real-Time PCR Detection System and CFX96™ Deep Well Real-Time PCR Detection System |
RealStar® MERS-CoV RT-PCR Kit U.S.*
| Release date: | 05/2020 |
RealStar® MERS-CoV RT-PCR Kit U.S.*
| Release date: | 12.02.2016 |
| Release date: | 12.02.2016 |
| Release date: | 12.02.2016 |
| Release date: | 12.02.2016 |