For PCR viral testing, the Hymon SARS-CoV-2 Test Kit manufactured by HymonBio, Co. Ltd, offers the following features:
- Test duration: 1.5 hours from start to finish.
- Sample type: NP and OP swabs.
- No RNA extraction. One step sample processing. All reagents included.
- Validated on ABI 7500, QuantStudio 5, QuantStudio 7, Bio-Rad CFX, and Roche LightCycler.
- Clinical evaluation: 100% performance agreement with other commercially available PCR tests
- Regulatory certifications: CE Mark, FDA EUA
See below for product related files for download.
Important details about Hymon SARS-CoV-2 PCR Test Kit:
- This test has not been FDA cleared or approved;
- This test has been authorized the FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For antibody testing, we offer an EUA Antibody IgM/IgG rapid test kits by Biotest:
Important details about the Biotest RightSign COVID-19 IgG/IgM Rapid Test Cassette:
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For additional information, contact us at info@cellebier.com.
