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COVID 19 Testing Kits

SARS-CoV-2 IgG / IgM Rapid Test Kit

Intended Use

The SARS-CoV-2 IgG/IgM Rapid Test Kit is used to qualitatively detect IgG and IgM antibodies of SARS-CoV-2 in human serum, plasma or whole blood. This device is intended to be used by professionals as a screening test and for SARS-CoV-2 research. Any reactive specimen with the SARS-CoV-2 IgG/IgM rapid test kit should be confirmed with alternative testing method(s). 

Click here for a introductory video on TBG's COVID-19 Testing Kits.

To report any adverse events, please see the section on "Regulations" shown below. 

* 添付文書はこちらをご覧ください。
Mode d’emploi en français disponible ci-dessous.

 

Feature and Benefits

  • Easy to Use with only 3 steps
  • Fast Results within 15 minutes
  • High Sensitivity with both N and S antigen coated

Specifications

  • Kit Contents: Disposable test card, disposable plastic capillary tubes, lancet, sample diluent, instructions for Use. 

  • Storage: CE (2 to 30°C for 12 months). FDA-EUA (2 to 8C for 9 months)
     

Workflow

User Protocol



NOTE: The fingerstick image is only for CE-marked products. U.S. product has NOT been FDA EUA authorized for use with fingerstick sample type.

Data Analysis
Negative
(陰性)
IgM Positive
(IgM陽性)
IgG Positive
(IgG陽性)
IgG / IgM Positive
(IgG/IgM陽性)

Ordering Information

Catalog. No. Package Sizes
No. 20010 25 tests/kit
No. 20010S 1 test/kit

Regulations

CE-IVD
FDA EUA

For reporting of adverse events related to this product, please send an email to COVID19@tbgbio.com and include the following within your email: 
- Product name and lot number. 
- Product operator and related testing facility. 
- Detailed description of the adverse event as well as the date of occurrence. 

All reported adverse events will be periodically updated and reported below. 
Currently Reported Adverse Events (Updated 8/12/2020): None Reported. 
 

Instruction Manuals

Name / Version Description Size
v1.5 User Manual (CE) 0.63MB
v1.2 User Manual (EUA) 2.63MB
v1.2 Control Set (only sold in U.S.) 0.13MB
v1.5 添付文書(日本語バージョン) 0.42MB
v1.5 Mode d’emploi en français 0.25MB

Product Documents

Name / Version Description Size
v2.7 DM 2.01MB
v2.3 Introduction and Testing Strategies 10.31MB
8-31-2020 Fact Sheet for Health Care Professionals 0.14MB
8-31-2020 Fact Sheet for Recipients 0.13MB