FDA-Device2016-06-08Class II
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine
Medscience Inc
Hazard
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Sold states
Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
Affected count
11,400 (Item 1000) & 380 (Item 1001)
Manufactured in
16469 Bridlewood Cir, N/A, Delray Beach, FL, United States
Products
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1843-2016Don't want to check this manually?
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