Rapid Antigen Test, Covid-19 (POC) (CLIA Waived)

Price : $250.00

Antigen Test, Covid-19 Point of Care (Must be CLIA-certified to purchase)

  • Buy 36 for $225.00 each and save 10%

** This item may only ship to a CLIA Waived Certified Facilities * This item is not intended for consumer use **

COVID-19 Antigen Test
A Rapid Immunoassay Antigen from Anterior nasal swab specimens.

Sensitivity and Specificity
COVID-19 (PPA 92.31%, NPA 99.04%)
Granted emergency use authorization (EUA) by the FDA
Visually read in 15 - 20 minutes
anterior nasal swab for superior comfort specimen collection and patient comfort

CPT Code Information
COVID-19: 87811Q

Status COVID-19 Features:
- Local Stock located in Michigan (Made in the USA (Q4 of 2021) and South Korea
- Test results are available in 15 - 20 minutes
- Antigen COVID-19 Test, Accurate detection with anterior nasal specimen swab! No more uncomfortable Nasopharyngeal collection
- The most efficient and cost-effective and comfortable testing platform for COVID-19
- Quality manufactured tests and results from No equipment needed to perform testing

- Lower operational costs and easier workflow compared to PCR & Reader based products


Specifications:
- Superior Sensitivity and Specificity
- COVID-19 (PPA 94%, NPA 100%)
- Only three components are needed to run the test; Test Cassette, Specimen Collection Swab, Reagent Capsule
- Anterior Swabs – Anterior Swab for superior specimen collection, comfort, ease of use, and testing results
- External controls - 1 positive, 1 negative control swab provided in each box
- Simple testing procedure - Fewer steps required compared to other COID-19 testing platforms

FAQ:
- Is this an antigen or antibody test?
The Status COVID-19 test is an antigen test, using the preferred anterior nasal swab specimen collection.
- What comes in a kit
25 test cassettes, 25 specimen collection tubes, 25 anterior nasal swabs, 25 collection tube droppers, 2 reagent bottles, 1 pos/1neg control swabs.
- What is expiration dating?
Currently 12 months from the date of manufacturing.
- What CPT code should be used?
There are CPT codes assigned for COVID-19,  87811QW (**the manufacturer, we cannot guarantee reimbursement values or standard billing procedures.)
- Is the Status COVID-19 CLIA Waived
Through the EUA approval process the FDA authorizes tests for use at the point of care (including COVID-19) under a EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

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"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 the 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 " 

Additional Information
Product Name Rapid Antigen Test, Covid-19 (POC) (CLIA Waived)
SKU COVAG025-NU
Price $250.00
Short Description

Antigen Test, Covid-19 Point of Care (Must be CLIA-certified to purchase)

Weight 2.500000
Featured Product No
Manufacturer Sku COVAG025-NU
UOM BX
Package Type BX
Manufacturer GenBody
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