Product code OYL— Immunology
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
- Classification name
- Tryptase Assay System
- Device class
- Class 2
- Regulation
- 21 CFR 866.5760
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
FDA classification definition
“An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.”
Market context for product code OYL
FDA has cleared devices under product code OYL between 2012 and 2018, filed by 2 applicant companies. 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.
Clearances per year
- 2018
- 2012
Top applicants under product code OYL
Recent clearances under product code OYL
- K173704 — ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
- DEN120001 — IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
Data sourced from openFDA. This site is unofficial and independent of the FDA.