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MSRP $206.25 You Save $68.75
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- Requires a CLIA Certificate Number
**This item can only be sold to high complexity or moderate complexity labs only.**
Fast Step Covid-19 IGG/IGM CLIA Waived Rapid Test
Contents:
- 20 Test Devices
- 20 Disposable Pipettes
- 20 Alcohol Prep Pads
- Sterile Safety Lancets
- Buffer
- Package Insert
CLIA Waived
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood specimens only 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.
The CLIA Waived COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only.
Indication:
Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.
About Test Device:
- EUA Authorized
- CE Mark
- Test does NOT give positive or negative result for COVID-19 virus. This is an antibody test, it only indicates past or recent infection.
- Read Results in 15 Minutes
- 9 Month Expiration from Date of Manufacture
SKU: COVID-19FS
This product has the following special restrictions:
- Requires CLIA Certification
- Commercial Address Delivery Only
- Product is not returnable
If the above restriction does not apply, please see our View Similar Products for alternative products without this restriction.
Free shipping (Continental USA)
No Cancellations; No Returns; All Sales Final. Drug and alcohol products are non-refundable due to the nature of these products. However, defective products may be returned for a full refund of the cost of the item excluding freight. In order to maintain our low prices, ALL SALES ARE FINAL AND NON-REFUNDABLE. ONCE PLACED, ORDERS CANNOT BE CANCELLED. However, we fully stand behind the quality of our products and customer satisfaction is our number one priority. NOTE: A 6-week quality investigation by ASC will occur on all requests for product returns.
**This item can only be sold to high complexity or moderate complexity labs only.**
- Requires a CLIA Certificate Number
- Non-Cancellable; Non-Returnable
American Screening:
American Screening LLC is the #1 Rapid Drug Test Manufacturer/ Distributor in America. We have been distributing high quality products throughout the World since 2003.
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