Kit, Igg, Platelet Associated
Kit, IgG, Platelet Associated is a diagnostic kit used to measure IgG immunoglobulins associated with platelet surfaces, used in the evaluation of immune-mediated thrombocytopenia, such as idiopathic thrombocytopenic purpura (ITP), where antibodies directed against platelets accelerate their destruction. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLG, regulated under 21 CFR 864.5425, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.
Research product code LLG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- LLG
- Device Class
- FDA class 2
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.