510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NIDClass II

Assay, Proliferation, In Vitro, T Lymphocyte

21 CFR 864.5220 / Hematology
FDA source (opens on fda.gov)

NID is the FDA product code for Assay, Proliferation, In Vitro, T Lymphocyte, a class II device type, regulated under 21 CFR 864.5220. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NID
Device name
Assay, Proliferation, In Vitro, T Lymphocyte
FDA 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.
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code NID

By decision year
2 clearances under product code NID with a decision year between 2002 and 2010, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NID by decision year
YearClearances
20021
20101

Applicants with the most clearances

Product code NID
Applicants holding the most 510(k) clearances under product code NID
ApplicantClearances
Cylex, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code