SWAB-N-GO HOME COVID 19 TEST KIT (2 tests per kit)
MADE IN USA
For large bids or RFP’s please send email to: [email protected]
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
MADE IN USA
- Anterior nasal swab specimens
- Results in 15 minutes
- 18-20 Months shelf life
- Store between 36 to 86° F
- Sample self-collection ages 14 and older
- Sample collection by an adult in children ages 2 to 13
- Excellent performance when compared to an FDA authorized molecular SARS-CoV-2 test.
2 Test Cartridges
1 Quick Reference Instructions
2 Extraction Buffer Tube(s)
2 Nasal Swab(s)
2 Nozzle Tubes for Buffer
1 Package Insert
“In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. The emergency use of 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.”
All EUA authorized COVID-19 products are non-returnable with no exceptions unless damaged in transit, product is recalled for manufacturer erformacne issues or deemed defective by the manufacturer. Buyer should beware that EUA authorized products could be revoked by FDA and removed from authorization list. Products that are revoked are non-returnable and non-refundable. Note: Manufacturer recalls are returnable for replacement product only. No Cash refund will be given for manufacturer-initiated recall.
