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4
High Level Disinfectants
The following liquid chemical germicides have received FDA 510(k) clearance for claims of
high level disinfection (HLD). Some HLD products may have multiple label claims and/or may
be FDA-cleared only for use in a legally marketed AER machine that can attain specific use
parameters (e.g., temperature).
Product Brand Name Manufacturer
Cidex
®
OPA
Cidex
®
OPA-C (used exclusively in EvoTech ECR)
Cidex
®
Activated Dialdehyde Solution(14-Day
Glutaraldehyde)
Advanced Sterilization Products
MetriCide
®
(Glutaraldehyde - may also be marketed
as Omnicide NS or MaxiCide
®
NS)
Metrex Research Corporation
Sporicidin
®
(Glutaraldehyde) Contec Incorporated
Rapicide
®
(Glutaraldehyde) Medivators Inc.
Wavicide
®
-01 (Glutaraldehyde) Medical Chemical Corporation
Sterilization Agents/Processes
The following agents/processes have received FDA 510(k) clearance for claims of sterilization:
Ethylene Oxide / Carbon Dioxide (80:20 gas mixture)
Ethylene Oxide / Carbon Dioxide (90:10 gas mixture)
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