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

Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

21 CFR 866.3900 / Microbiology
FDA source (opens on fda.gov)

LFY is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster, a class II device type, regulated under 21 CFR 866.3900. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
LFY
Device name
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Regulation
21 CFR 866.3900
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
4

Clearances, product code LFY

By decision year
17 clearances under product code LFY with a decision year between 1983 and 2023, 1992 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LFY by decision year
YearClearances
19831
19841
19891
19901
19922
19951
19962
19971
19981
19991
20051
20072
20151
20231

Applicants with the most clearances

Product code LFY
Applicants holding the most 510(k) clearances under product code LFY
ApplicantClearances
Zeus Scientific LLC4
Diasorin Inc.3
Diamedix Corp.2
Biomerieux Vitek, Inc.1
Bionetic Laboratory Products1
Biowhittaker Molecular Applications, Inc.1
Clinical Sciences, Inc.1
Gull Laboratories, Inc.1
M.A. Bioproducts1
Pharmacia Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code