FDA-Device2016-09-28Class II
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
Siemens Healthcare Diagnostics, Inc.
Hazard
24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.
Sold states
Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted
Affected count
525 units
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2841-2016Don't want to check this manually?
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