Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase

No FDA recalls found in the data synced 6 Oct 2026.

De Novo Number

DEN120001 ↗

FDA Product Code

OYL

Device Class

Class II

Regulation

21 CFR Part 866.5760

Advisory Committee

Immunology

FDA Decision

DENG De Novo granted

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See all devices from Phadia Us Inc. →

• What is the Immunocap Tryptase used for?

  The Immunocap Tryptase is used as a tryptase assay system in the immunology medical specialty, in conjunction with calibrators, curve control, and conjugate 50.

• What components are included with the device?

  The device is supplied with various components, including calibrators, curve control strips, a calibrator strip, and a curve control strip, as well as an anti-tryptase component.

• How is the device regulated?

  The device is classified as a class 2 device and is regulated under the regulation number 866.5760, with a product code of OYL.

• What is the manufacturer of the device?

  The device is manufactured by Phadia US, Inc.