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Access Bio CareStart COVID-19
Antigen Test

88.40%

Sensitivity (PPA)

100.00%

Specificity (NPA)

10

Results at 10 Minutes

20 tests per box.
Access Bio CareStart COVID-19 Antigen Test is made in the USA..
CE Certified.
FDA EUA Authorized.

As intended point-of-care (POC) designated test with a 10 minute processing time, CareStart Covid 19 Antigen Test allows effective diagnosis of COVID-19 infection. Designed as CLIA waived test. (CLIA Waiver Certificate number required at time of purchase). 

Store the Access Bio CareStart COVID-19 Antigen Test kit at 1-30˚C (33.8-86 degrees F)

Access Bio CareStart COVID-19 Antigen Test requires no special equipment to read test results.

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. Authorized for POC use by qualified healthcare professionals. 

This product has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

 

Product Name: Access Bio CareStart COVID-19 Antigen Test

SKU:  SV33

Country of Manufacturer: USA

Sample Type: Nasopharyngeal, Lower Nasal

Sensitivity: 88.40%

Specificity: 100.00%

Test Procedure: 5 steps

Test Run Time (minutes): 10 minutes

Mobile App: No

Package dimensions  (20 tests): 9 x 6 x 3 inch
Package Weight (20 tests):  .72 lbs.
Case Dimensions (640 tests):  21x20x14 inch
Case Weight (640 tests):  23 lbs.
Swab Included:  Yes (Nasopharyngeal, Lower Nasal)
Storage Temp (In Celsius):  1C-30C
Shelf Life:  6 months from date of manufacturer
Internal Control Included:  No
EUA Status:  FDA EUA Authorized
CE Status:  Certified
Availability:  Immediate