FDA-Device2019-05-08Class II
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
PerkinElmer Life and Analytical Sciences, Wallac, OY
Hazard
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Sold states
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Affected count
31 kits (10 in US, 21 in ROW)
Manufactured in
Mustionkatu 6, P.O. Box 10, Turku, N/A, Finland
Products
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2019Don't want to check this manually?
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