Detergent
A laboratory detergent is a cleaning and reagent-grade surfactant solution used in clinical and research pathology laboratories for washing equipment, glassware, and specimens, ensuring removal of contaminants that could interfere with diagnostic procedures. It is classified as FDA Class 1, the lowest risk designation, and is exempt from Good Manufacturing Practice requirements as well as premarket notification. The product code is JCB, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- JCB
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 44 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 44 registration numbers. Click on an entry to view related FDA registrations.