Product Code: DLR
FDA class 2
21 CFR 862.3640
Hemagglutination Inhibition, Morphine
Clinical Toxicology
The Hemagglutination Inhibition test for Morphine is a clinical laboratory immunoassay that detects morphine in patient specimens by measuring inhibition of red blood cell agglutination, used for toxicological screening and monitoring. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DLR, regulated under 21 CFR 862.3640, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
3
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Basic Information
- Product Code
- DLR
- Device Class
- FDA class 2
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.