FDA-Device2024-04-03Class II
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.
Hologic, Inc.
Hazard
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Sold states
Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL, MD, MI, MO, TN, TX, WI and the countries of Australia, Germany, Denmark, Spain, France, Great Britain, Italy, Norway, Qatar, Sweden.
Affected count
684 kits
Manufactured in
10210 Genetic Center Dr, N/A, San Diego, CA, United States
Products
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2024Don't want to check this manually?
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