CareStart COVID-19 OTC Antigen Home-Test

AccessBio CareStart Covid-19 Antigen Home Test

EXP DATE: September 12, 2024

FDA Extension Letter

Package Size: Kit Box of 2 Tests

FDA EUA Authorized

Self-Test for SARS-CoV-2 Antigen Detection

The test applies to both symptomatic and asymptomatic individuals. Easy and Fast accurate results in less than 15 minutes of instruction included.

Features

• Fast and easy to self-test anywhere
• Easy to interpret the results using a mobile application
• Qualitatively detect the SARS-CoV-2 nucleocapsid protein
• Use for nasal swab specimen
• Fast results only in 10 minutes
• Identify the individual’s current infection status for COVID-19

CareStart Covid-19 Antigen Home Test Instructions

Instructional Video

Important Documention

FACT SHEET FOR HEALTHCARE PROVIDERS
USER INSTRUCTIONS (QRI) AND FACT SHEET FOR INDIVIDUALS
INSTRUCTIONS FOR USE (IFU) FOR HEALTHCARE PROVIDERS
FDA EMERGENCY USE AUTHORIZATION LETTER
FDA EXTENSION LETTER

BULK ORDERS

Please call us at +1 877-597-3224 for bulk orders or click here to learn about our Commercial accounts and B2B Wholesales discounts.

Disclaimer

• As of November 22, 2021, the CareStart™ COVID-19 Antigen Home Test is authorized to be used with individual anterior nasal swab specimens from individuals aged 14 years and older (self-collected), or 2 years and older (collected with adult assistance) for non-prescription home use by FDA under the EUA (EUA210314/S002). The authorized labeling has been changed with the new indication (Quick Reference Instructions (QRI) and Fact Sheet for Individuals, Instructions for Use (IFU) for Healthcare Providers (HCP), Fact Sheet for HCP, and kit package); however, CareStart™ COVID-19 Antigen Home Test will continue to be distributed with the labeling previously authorized per EUA210314/S001 on the FDA’s enforcement discretion in efforts to increase the testing accessibility for COVID-19. Since the differences between the CareStart™ COVID-19 Antigen Home Test kit previously authorized (EUA210314/S001) and currently authorized (EUA210314/S002) are limited to the authorized labeling, you may use the CareStart™ COVID-19 Antigen Home Test kit with the new indication for use (described above).

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.

For B2B accounts, please contact us at sales@pechmedical.com for urgent order requests.

Please feel free to contact support@peachmedical.com if you have any questions.

What Shipping Methods Do You Offer?

At Peach Medical we use UPS (most orders ship via UPS but some may ship via USPS) as our logistic and Shipping partners. We currently offer the following services:

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 cannot have packages rerouted or contact the carrier on your behalf.

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 get in touch with the customer service team to see if you are eligible.

Return Policy and Cancellation Policy

All sales are final. If items are found defective, the customer has 7 Business Days to request a return label. We are not responsible for any delays caused by shipping companies, ie: UPS, FedEx, DHL, Freight.

If a customer chooses a 3rd party receiver who is not the purchaser, Peach Medical is not responsible for any goods once it leave our warehouse and when tracking is provided. I.e Gifts, International Shipping Services.

Note: If Peach Medical has not shipped your item within 7 business days, cancellations will be honored.