Assay, T Lymphocyte Surface Marker
A T lymphocyte surface marker assay is a laboratory hematology test used to identify and quantify T lymphocytes by detecting specific cell-surface antigens, supporting the assessment of immune function, T-cell subset analysis, and the diagnosis of T-cell malignancies and immune deficiency disorders. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance. It carries product code LIZ and is regulated under 21 CFR 864.5220 within the Hematology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LIZ
- Device Class
- FDA class 2
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914847 | CD8 MONOCLONAL ANTIBODIES | Jun 19, 1992 | Substantially Equivalent | Gen Trak, Inc. |
| K860830 | TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD | Sep 08, 1986 | Substantially Equivalent for Some Indications | Technicon Instruments Corp. |
| K843062 | TBM-REAGENT FOR T,B CELL & MONOCYTES | Apr 03, 1985 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K842218 | ANTI-LEU-4 FITC LYSIN C BUFFER | Dec 27, 1984 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K833929 | WHITE BLOOD CELLS HUMAN TAND B | Feb 03, 1984 | Substantially Equivalent | Control Diagnostics |
| K831053 | QUANTIGEN T & B CELL ASSAY | Aug 08, 1983 | Substantially Equivalent | Bio-Rad |
| K820643 | ORTHO SPECTRUM III & ORTHO-MUNE OK | Jul 14, 1982 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.