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- Requires a CLIA Certificate Number
- Orders are Non-Cancellable; Item is Non-Returnable
Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen - Results in 15 minutes
GenBody COVID-19 Antigen Rapid Test Kit
Anterior Nasal Swab
Expiry: Weekly production. One year from the date of manufacturing
Detection kit for SARS-CoV-2 antigen in nasopharyngeal or anterior nasal swab specimens.
Rapid detection of SARS-CoV-2 will play a key role in the global spread of the virus.
Affordable and sensitive test that does not require an additional reader, with a processing time of 15-20 minutes.
GenBody COVID-19 Antigen Rapid Test Kit
Anterior Nasal Swab
Features
- Detects SARS-CoV-2 nucleocapsid protein antigen
- Rapid results in 15-20 minutes
- Anterior nasal swab specimen collection
- Identifies acute infection with a 92.31% sensitivity and 99.04% specificity
- For use in patient care settings operating under a
- CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
- The confirmed LoD for the GenBody COVID-19 Ag is 1.11 x 10 TCID50/mL.
- FDA EUA: EUA210249
Our competitive advantage
- Large manufacturing capacity and immediately available for distribution
- Global sales and regulatory approval throughout Europe, Asia and South America
- Selected by NIH for the Rapid Acceleration of Diagnostics program, for the US production of the GenBody COVID-19 Ag test.
- Made in the USA (Q4 2021) and South Korea
- The GenBody COVID-19 Ag test detects the SarsCoV-2 variants.
MATERIALS PROVIDED
Kit Component: Kit Component, Device
Quantity: Twenty-five (25) single use Test Devices
Description: Individually pouched devices with a desiccant. Test Device contains one reactive test strip. The test strip contains a membrane coated with mouse anti-SARS-CoV-2 NP antibodies for the test line and mouse anti-Nus tag antibodies for the control line, and a conjugate pad impregnated with Mouse anti-SARS-CoV-2 NP antibodies and recombinant Nus tag antigens
Kit Component: Extraction Solution
Quantity: Two (2) bottles containing 9 mL of Extraction Solution
Description: Buffer with detergent and preservative (< 0.1% sodium azide)
Kit Component: Extraction Tube
Quantity: Twenty-five (25) single use tubes
Description: Flexible plastic tube for extraction of sample
Kit Component: Dropper Tips
Quantity: Twenty-five (25) single use dropper tips
Description: Disposable of the Extraction Tube for dispensing the extracted sample
Kit Component: Sterilized Nasopharyngeal or Anterior Nasal Swabs
Quantity: Twenty-five (25) single use specimen sampling swabs
Description: Swab for nasopharyngeal or anterior nasal sample collection with a flexible/breakable handle
Kit Component: External Positive Control Swab
Quantity: One (1) single use swab
Description: Individually pouched swab coated with noninfectious recombinant SARS-CoV-2 protein antigen on the head
Kit Component: External Negative Control Swab
Quantity: One (1) single use swab
Description: Individually pouched swab coated with buffer on the head
Kit Component: Instructions for Use (IFU)
Quantity: One (1)
Description: Instructions for use
Kit Component: Quick Reference Instructions (QRI)
Quantity: One (1)
Description: Quick reference instructions
MATERIALS REQUIRED BUT NOT PROVIDED
- Timer
- Any necessary personal protective equipment including gloves
Covid Attributes:
Type: Antigen / Rapid
Use: Lab / Clinical
Certification: CLIA Certificate Required for purchase
Sample SpecimenType: Nasal Swab
Availability: Ready to ship (typically ships within 7 days)
HCPCS: EUA210249
Origin of Manufacture: USA
This product has the following special restrictions:
- Requires CLIA Certification
- Product is not returnable
$9.95 Flat Rate GND (1-5 BUS DAYS), in continental USA. Free shipping on $2500 and above. Exclusions may apply.
No Cancellations; No Returns; All Sales Final. Exclusions may apply. All returns must be approved by our Returns Department. An e-mail notification will be issued regarding your return status and return instructions, should this apply. Any product returned for credit without an authorized RMA number clearly printed on the outside package or shipping label will be refused. Unauthorized returns will not be honored or accepted for credit.
Rx Only
For use under the EUA Only
For use under an Emergency Use Authorization (EUA) Only
For in vitro diagnostic use only
For professional use only
SLI Medical:
SLI Medical Supply (SLI) delivers medical supplies and health care technology solutions for every health care setting. SLI Medical is committed to creating a health care system that leads to lower costs, higher inefficiencies and better health for physician's patients.
We distribute products from a wide variety of manufacturers to distributors and re-sellers worldwide.
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