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EUA-GenBody-COVIDAg-letter-2022
Instruction-for-use
GenBody Package Insert
EUA-GenBody-Patient Fact Sheet
EUA-GenBody-Provider Fact Sheet
GenBody Competitive Advantages
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories. CLIA WAIVED
Contents: Test device (25), Extraction solution (2), Extraction Tubes (25), Dropper Tips (25), swabs (25), Positive control swab (1), Negative control swab (1) each, Instructions for use (1) Quick Reference Instructions (QRI) (1)
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Storage Requirements: 2° – 30° C
Processing Time: Approximately 15 Minutes
CPT Code: 87811QW
Backed by the NIH, the GenBody Covid-19 Antigen Test, The GenBody COVID-19 Ag test is a rapid, qualitative immunochromatographic assay for the determination of the presence of SARS-CoV-2 antigens in human nasopharyngeal or anterior nasal swab specimens. The test strip in each device contains mouse monoclonal antibodies to the nucleocapsid protein (NP) of SARS-CoV-2.
Highlights include:
- Detects SARS-CoV-2 nucleocapsid protein antigen
- Rapid results in 15-20 minutes
- Identifies acute infection with a 91.1% sensitivity and 100% specificity
- For use in patient care settings operating under a
- CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation
The GenBody COVID-19 Ag is intended for use by medical professionals or operators trained in performing tests
in point of care settings. The GenBody COVID-19 Ag is only for use under the Food and Drug Administration’s
Emergency Use Authorization.
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.
Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen
COVID-19 tests are non-returnable
*Copy of CLIA Waiver required to be submitted with purchase*
- 100% Satisfaction
- Money Back Guaranteed
- 30 days return policy
Shipping:
- Please allow between 5-10 days for your order to arrive. If more than 20 days have passed please email us at support@diskatech.com to review the status of your order. Refunds will be handled through email if necessary.
Returns:
- Our policy lasts 30 days. If 30 days have gone by since your order was received, unfortunately, we can’t offer you a refund or exchange.
- To be eligible for a return, your item must be unused and in the same condition that you received it. It must also be in the original packaging.
- Additional non-returnable items:
- Gift cards
- Downloadable software products
- To complete your return, we require a receipt or proof of purchase.
- Please do not send your purchase back to the manufacturer.
- There are certain situations where only partial refunds are granted (if applicable)
- Book with obvious signs of use CD, DVD, VHS tape, software, video game, cassette tape, or vinyl record that has been opened Any item not in its original condition is damaged or missing parts for reasons not due to our error
- Any item that is returned more than 15 days after delivery
Refunds (if applicable)
- Once your return is received and inspected, we will send you an email to notify you that we have received your returned item. We will also notify you of the approval or rejection of your refund.
- If you are approved, then your refund will be processed, and a credit will automatically be applied to your credit card or original method of payment, within a certain amount of days.
- Late or missing refunds (if applicable)
- If you haven’t received a refund yet, first check your bank account again.
- Then contact your credit card company, it may take some time before your refund is officially posted.
- Next, contact your bank. There is often some processing time before a refund is posted. If you’ve done all of this and you still have not received your refund yet, please contact us at support@diskatech.com.
Sale items (if applicable)
- Only regular priced items may be refunded, unfortunately, sale items cannot be refunded.
Exchanges (if applicable)
- We only replace items if they are defective or damaged. If you need to exchange it for the same item, send us an email at support@diskatech.com and send your item to: 2509 Livenza Pl., Leander, TX 78641
Gifts
- If the item was marked as a gift when purchased and shipped directly to you, you’ll receive a gift credit for the value of your return. Once the returned item is received, a gift certificate will be mailed to you.
- If the item wasn’t marked as a gift when purchased, or the gift giver had the order shipped to themselves to give to you later, we will send a refund to the gift giver and he will find out about your return.
Shipping
- To return your product, you should mail your product to: 2509 Livenza Pl, Leander TX 78641
- You will be responsible for paying for your own shipping costs for returning your item. Shipping costs are non-refundable. If you receive a refund, the cost of return shipping will be deducted from your refund.
- Depending on where you live, the time it may take for your exchanged product to reach you may vary.
- If you are shipping an item over $75, you should consider using a trackable shipping service or purchasing shipping insurance. We don’t guarantee that we will receive your returned item.
