LifeSign Status Strep A Strip Test (30 Tests) – CLIA Waived, Rapid Results

LifeSign Status Strep A Strip Test (30 Tests) – CLIA Waived, Rapid Results

Exp Date: December 31st, 2024

FDA Extension Letter

Physician's licensing is required. Not for at-home use.

Elevate your diagnostic capabilities with the LifeSign Status Strep A Strip Test (#34130 / 30 Tests per box). This CLIA-waived, rapid immunochromatographic assay ensures easy extraction for swift reaction times and provides accurate results in just 5-10 minutes. Designed for professional use in physician's offices, hospitals, and clinical laboratories, this kit includes a convenient resealable canister with 25 test strips, along with external negative and positive controls.

Key Features:

• CLIA waived for hassle-free testing.
• Simple, easy-to-follow procedure.
• Fast reaction times with easy extraction.
• Results are available in 5-10 minutes.
• External negative and positive controls are included.
• FDA Approved
• American Made

Specifications:

• Sensitivity: 96.2%
• Specificity: 98.7%

Unlock precise group A streptococcal antigen detection directly from throat swab specimens. Trust the Status Strep A Strip Test for superior sensitivity and specificity. Physician's licensing is required. Not for at-home use. Elevate your diagnostic accuracy today.

FAQ

1. Is the LifeSign Status Strep A Strip Test suitable for at-home use?
   • No, the LifeSign Status Strep A Strip Test is not intended for at-home use. Physician's licensing is required, and the test should be completed in a professional lab facility.
2. How long does it take to get results with the LifeSign Status Strep A Strip Test?
   • Results are typically ready in as little as 5-10 minutes, offering a rapid and efficient diagnostic solution.
3. What does CLIA waived mean, and why is it important for this strep test?
   • CLIA waived indicates that the test has met specific regulatory standards for simplicity and reliability, making it suitable for use outside traditional laboratories. This designation ensures ease of use without sacrificing accuracy.
4. Can the LifeSign Status Strep A Strip Test be used in various healthcare settings?
   • Yes, this test is versatile and suitable for use in physician's offices, hospitals, and clinical laboratories, providing flexibility in different healthcare environments.
5. Are external negative and positive controls included with each kit?
   • Yes, the LifeSign Status Strep A Strip Test comes with both external negative and positive controls, enhancing the reliability of your testing process.
6. Is there a warranty for the LifeSign Status Strep A Strip Test?
   • No, there is no warranty available for this product. However, it is delivered in factory-new condition to ensure the highest quality upon receipt.
7. How should the LifeSign Status Strep A Strip Test be stored when not in use?
   • Store the test strips in the provided resealable canister in a cool and dry place. Follow the recommended storage conditions outlined in the product instructions for optimal performance.

Important Documents

Brochure

User Manual

LifeSign Status Strep A Strip Package Insert

LifeSign Status Strep A Strip SDS

LifeSign Status Strep A Strip Sell Sheet

FDA Extension Letter

Shipping and Returns

How Long Does It Take For My Item(s) To Ship?

Items are shipped Monday - Friday from our warehouse. 1-2 Day Processing Time.

Delivery times vary according to your selected delivery address, the availability of your items, and the time of day you place your order.

For B2B accounts, please get in touch with us at sales@pechmedical.com for urgent order requests.

Please feel free to visit our Support Page for FDA Extension Letters, Submit a Ticket, and more.

What Shipping Methods Do You Offer?

At Peach Medical Corp we use UPS (most orders ship via UPS but some may ship via USPS) as our logistic and Shipping partners. Currently, our shipping methods are as follows:

• UPS Next Day Air
• UPS 2nd Day Air
• UPS Ground (3-5 Day Delivery)

When Will I Receive My Tracking Number?

Our system updates clients every evening with tracking numbers for their orders. This will be sent via e-mail with an additional copy of your receipt.

Incorrect Address

Please verify your address when ordering, we are unable to fix an incorrect shipping address on an order once it is in transit. If your order is in transit with an incorrect address, please reach out to your carrier to reroute the package. Peach Medical Corp. is not able to have packages rerouted or contact the carrier for you.

Refunds will not be issued for packages that were shipped to an incorrect address but it may be possible for a replacement package to be sent, please contact the customer service team to see if you are eligible.

Return Policy and Cancellation Policy

The Peach Medical COVID-19 Antigen Rapid Test and all face masks are Non-returnable & Non-refundable as they are considered personal-use items. Replacement may be shipped if the item is defective. Proof of purchase, photos of defects, lot numbers, and other information are required to authorize a replacement. Please reach out to customer service for detailed requirements before disposing of the defective units. We will not replace your COVID-19 Antigen Rapid Test kits that are expiring soon based on the printed label. Our expiration dates have been shown on each product page. More information can be found at support.peachmedical.com/portal/en/kb/peachmedicalsourcing. We will continue to update the FDA documents for shelf-life extensions for our tests.

If a customer chooses a 3rd party receiver who is not the purchaser, Peach Medical is not responsible for any goods once they leave our warehouse and when tracking is provided. I.e Gifts, International Shipping Services. All Products must be packed in the original, unopened, and unmarked packaging including any accessories, manuals, documentation, and registration that shipped with the Product.

Note: If Peach Medical has not shipped your item within 7 business days, cancellations will be honored. Please email us at support@peachmedical.com for return authorization and the shipping address.