Product code OYP— Microbiology

STRATIFY JCV DXSELECT

Classification name: Anti-Jcv Antibody Detection Assay
Device class: Class 2
Regulation: 21 CFR 866.3336
Advisory panel: Microbiology
Total cleared: 2
First cleared: 2012-01-20
Most recent: 2012-08-16

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code OYP under 21 CFR 866.3336, via openFDA

Market context for product code OYP

FDA has cleared 2 devices under product code OYP, all in 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OYP

Focus Diagnostics, Inc.2 clearances

Recent clearances under product code OYP

K120986 — STRATIFY JCV DXSELECTFocus Diagnostics, Inc.·2012-08-16
DEN120008 — STRATIFY JCV(TM) ANTIBODYFocus Diagnostics, Inc.·2012-01-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.