Lactic Dehydrogenase, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting lactic dehydrogenase (LDH), a ubiquitous intracellular enzyme released into the bloodstream upon cell damage or death, including antigen, antiserum, and control components for clinical laboratory immunoassay applications. LDH is used as a nonspecific marker of tissue injury, hemolysis, and certain malignancies. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is DET, regulated under 21 CFR 866.5560, within the Immunology specialty.
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Basic Information
- Product Code
- DET
- Device Class
- FDA class 1
- Regulation Number
- 866.5560
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K900107 | LD-1 | Jan 18, 1990 | Substantially Equivalent | Boehringer Mannheim Corp. |