FDA-Device2017-07-05Class III
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Medtest Holdings, Inc.
Hazard
Linear performance information in product insert does not match that listed in the approved premarket notification
Sold states
Nationwide Distribution
Affected count
319.922 L
Manufactured in
5449 Research Dr, N/A, Canton, MI, United States
Products
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2650-2017Don't want to check this manually?
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