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Specification
Brand : iHealth
BulletPoint : Step by Step Guide to safely sample for asbestos Accredited Laboratory 72hr (3 business days) results Residential or Commercial Use This kit includes: - a mask - disposable gloves - an instructional booklet - sample(s) bags - **Cost for analysis included in the kit**
BulletPoint1 : FDA AUTHORIZED 15-MINUTE FLU A&B, COVID TEST KIT. This antigen rapid test kit is FDA authorized and designed for use in point-of-care settings, enabling healthcare providers to make quick and informed decisions in just 15 minutes.
BulletPoint2 : EASY-TO-FOLLOW 4 STEPS; GET 3 RESULTS IN 1 TEST. This fully integrated test kit features a straightforward process. By following the 4 user-friendly steps, you can obtain results for COVID-19 and Flu A&B simultaneously with just 5 drops of sample.
BulletPoint3 : LONG SHELF LIFE. The COVID and flu test kit offers a 14-month shelf life, ensuring it remains effctive and ready for use over an extended period.
BulletPoint4 : ROOM TEMPERATURE STORAGE. The test kit is designed for convenient storage at room temperature, eliminating the need for refrigeration and simplifying logistics.
BulletPoint5 : MADE FOR AGES 2 AND ABOVE. With a non-invasive swab, this test kit is suitable for anyone aged 2 years and older, making it a versatile option for testing across di erent age groups.
Color : A
ExternallyAssignedProductIdentifier : 7661970220213
ExternallyAssignedProductIdentifier1 : 850044118656
ExternallyAssignedProductIdentifier2 : 0850044118656
FcShelfLife : 510 days
FdaDeviceClassification : ii
FdaIndicationOfUse : otc
FdaInstructionsForUseType : consumer
FdaLabelType : consumer
IncludedComponents : disposable gloves, mask, instructional guide and 5 sample bags
IsExpirationDatedProduct : 1
ItemName : iHealth COVID-19/Flu A&B Rapid Test Pro (25 Tests per kit, Point of Care only)
ItemPackageDimensions_Height : 4.45 inches
ItemPackageDimensions_Length : 6.3 inches
ItemPackageDimensions_Width : 5.31 inches
ItemPackageQuantity : 1
ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits
Manufacturer : iHealth Labs, Inc.
Material : Stainless Steel
NumberOfBoxes : 1
NumberOfItems : 25
PackageLevel : unit
PartNumber : ICF-3000P
ProductDescription : The iHealth COVID-19/Flu A&B Rapid Test Pro is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first four (4) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to 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 test 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.
ProductExpirationType : Expiration On Package
ProductSiteLaunchDate : 2024-09-02T11:00:00.000Z
SupplierDeclaredDgHzRegulation : not_applicable
SupplierDeclaredHasProductIdentifierExemption : 1
UnitCount : 1
UnspscCode : 46150000