TBG Biotechnology Corp.
TBG SARS-CoV-2 IgG / IgM Rapid Test Controls Set
Version 1.2
2 of 20
laboratories certified under CLIA, that meet requirements to perform moderate or
high complexity tests; This product has been authorized for use with the TBG
SARS-CoV-2 IgM/IgG Rapid Test Kit for the presence of IgG and IgM antibodies
against SARS-CoV-2, not for any other viruses or pathogens; and This product 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. The
emergency use of your product as described in this letter of authorization.
6.3.
The controls are intended for professional use only.
6.4.
Please read this manual carefully before using this control product.
6.5.
The quality controls should be used prior to the expiration date indicated on the
label.
6.6.
Warning: This product contains human source and or potential infectious
ingredients. Please refer to the main components section of this manual. There is
no known method to fully guarantee that human source materials or inactivated
microorganisms are not infectious. Therefore, all human source materials should
be regarded as potential infectious.
6.7.
Discard contents/containers in accordance with local regulations.
6.8.
The product is only suitable for the quality control of TBG SARS-CoV-2 IgG / IgM
Rapid Test Kit.
7.
Bibliography:
None
8.
Trademarks Used in this Document:
TBG Biotechnology Corp.
9.
Patents Used in this Document:
None
For Emergency Use Authorization (EUA) Only
TBG Biotechnology Corp., 13F-1, No.237, Sec.1, Datong Rd, Xizhi Distr., New Taipei
City, Taiwan 221
Telephone: +1 877-822-2461 Website:
www.tbgbio.com
Email:[email protected]
