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

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

21 CFR 866.3305 / Microbiology
FDA source (opens on fda.gov)

MYF is the FDA product code for Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2, a class II device type, regulated under 21 CFR 866.3305. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MYF
Device name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Regulation
21 CFR 866.3305
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
No
Ingested clearances
10
Ingested recalls
2

Clearances, product code MYF

By decision year
10 clearances under product code MYF with a decision year between 2000 and 2025, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MYF by decision year
YearClearances
20001
20041
20071
20081
20111
20161
20181
20191
20221
20251

Applicants with the most clearances

Product code MYF
Applicants holding the most 510(k) clearances under product code MYF
ApplicantClearances
Biokit, S.A.2
Quest International, Inc.2
Diasorin Inc.1
Euroimmun US Inc.1
Mrl Diagnostics1
Roche Diagnostics GmbH1
Trinity Biotech USA1
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code