FDA-Device2019-10-16Class II
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Helena Laboratories, Corp.
Hazard
The plates do not have wells punched for the controls in the patient 1 area.
Sold states
Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.
Affected count
24 kits
Manufactured in
1530 Lindbergh Dr, N/A, Beaumont, TX, United States
Products
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0045-2020Don't want to check this manually?
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