- COVID-19 Antigen Rapid Test Kits (CLA-COV19AG-VIS)

SKU: CLA CLA-COV19AG-VIS
Shipping Weight: 75 ounces
HCPCS: EUA210062
Origin of Manufacture: FINLAND

This product has the following special restrictions:

- Requires CLIA Certification
- Product is not returnable
- Product is not cancellable

Flat Rate $9.95 in Continental US. Drop Ship $15.00. Exclusions apply. F.O.B. Destination greater than $2,000 + $30 ship charge + (FRC) of 1.35% on product total. FRC % is subject to change w/o notice.

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.

The Clarity COVID-19 Antigen test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high complexity, moderate complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- Requires a CLIA Certificate Number
- Non-Cancellable; Non-Returnable

- Requires a CLIA Certificate Number for purchase
- Orders are Non-Cancellable; Item is Non-Returnable

THE CLARITY COVID-19 ANTIGEN RAPID TEST CASSETTE IS NOW EUA, CLIA WAIVED AND POCT APPROVED

Clarity COVID-19 Antigen Rapid Test Kits, Includes:
(25) Tests
(25) NP Swabs
(25) Buffers
Package Insert
QSG
(1) Negative Control
(1) Positive Control/kt

Product Inserts Include:
- Clarity CLA-COV19AG-VIS Package Insert
- Fact Sheet for Healthcare Providers
- Fact Sheet for Recipients

CLARITY COVID-19 ANTIGEN RAPID TEST CASSETTES
Benefits:
- FDA Emergency Use Authorized (EUA), CLIA Waived and POCT approved.
- Relative Sensitivity 87.5%
- Relative Specificity: >98.9%
- Fast and Easy - Positive results as fast as 5 minutes
- Test Naso-Pharyngeal Swab immediately, or store at room temperature and test within 1 hour.
- Naso-Pharyngeal Swab stored in a dry tube at 2-8c can be tested within 24 hours.
- EUA #: EUA210062

Product Codes
CLA-COV19AG-VIS (25/box)
Contains: 25 Individually pouched test cassettes, 25 Sterile Naso-Pharyngeal Swabs, 25 Buffer Tubes, 1 Negative Control Swab, 1 Positive Control Swab, 1 Work Station, 1 Package Insert, 1 Quick Start Guide.

IMPORTANT INFORMATION
The Clarity COVID-19 Antigen test can be used to test directly collected naso-pharyngeal swab specimens.
The Clarity COVID-19 Antigen test should be ordered for the detection of COVID-19 antigen in individuals who are suspected of COVID-19 by their healthcare provider and who are within six days of symptom onset.
The Clarity COVID-19 Antigen test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high complexity, moderate complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Our CLIA Waiver can be found on the FDA's website at the following link: https://www.fda.gov/media/149056/download

Covid Attributes:
Type: Antigen / Rapid
Use: Lab / Clinical
Certification: CLIA Certificate Required for purchase
Sample SpecimenType: Nasal Swab
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