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Assay, Proliferation, In Vitro, T Lymphocyte

Assay, Proliferation, In Vitro, T Lymphocyte is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Assay, Proliferation, In Vitro, T Lymphocyte
Hematology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NID

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Class 2

21 CFR 864.5220

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Hematology

Device Characteristics

No

No

No

Eligible

Definition

A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-specific added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient.