Product Details
Authorized Laboratories:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Product Resources
- EUA Language
- Provider Fact Sheet
- Patient Fact Sheet
- Instructions for Use
- External Controls
- Quick Reference Guide
Offer Controls: "Available upon request"
- GCFC-PN2 : 1 Each Negative and Positive Control Swabs
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GCFC-PN20 : 10 Each Negative and Positive Control Swabs
