Stratify JCV Dxselect
FDA 510(k) K120986 · Focus Diagnostics, Inc.
510(k) numberK120986
Submission
- Device name
- Stratify JCV Dxselect
- Applicant
- Focus Diagnostics, Inc.
Cypress, CA, US - Received
- April 2, 2012
- Decision date
- August 16, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OYP – Anti-Jcv Antibody Detection Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3336
- Specialty
- Microbiology
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.
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Questions and answers
When was Stratify JCV Dxselect cleared by the FDA?
Stratify JCV Dxselect (K120986) received a 510(k) decision of Substantially Equivalent on August 16, 2012, 136 days after the submission was received.
What is the product code of K120986?
The FDA product code is OYP – Anti-Jcv Antibody Detection Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3336.