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

Anti-Jcv Antibody Detection Assay

21 CFR 866.3336 / Microbiology
FDA source (opens on fda.gov)

OYP is the FDA product code for Anti-Jcv Antibody Detection Assay, a class II device type, regulated under 21 CFR 866.3336. FDA's definition for this code reads: "The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OYP
Device name
Anti-Jcv Antibody Detection Assay
FDA definition
The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies.
Regulation
21 CFR 866.3336
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
2
Ingested recalls
1

Clearances, product code OYP

By decision year
2 clearances under product code OYP with a decision year between 2012 and 2012, 2012 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OYP by decision year
YearClearances
20122

Applicants with the most clearances

Product code OYP
Applicants holding the most 510(k) clearances under product code OYP
ApplicantClearances
DiaSorin Molecular LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code