Test Reagents For Ethyl Alcohol
Test Reagents for Ethyl Alcohol are clinical toxicology reagents used in laboratory assays to detect and measure ethanol concentrations in blood, urine, or other biological specimens. This is a Class 2 device requiring 510(k) premarket clearance to demonstrate substantial equivalence prior to marketing. The product code is DMJ, regulated under 21 CFR 862.3040, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DMJ
- Device Class
- FDA class 2
- Regulation Number
- 862.3040
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.