FDA-Device2018-05-23Class II
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
Tosoh Bioscience Inc
Hazard
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Sold states
USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Affected count
2258
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2018Don't want to check this manually?
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