De Novo DEN120001

Device: IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
Contact: martin mann
De Novo number: DEN120001
Product code: OYL
Regulation: 866.5760
Classification name: tryptase assay system
Decision: granted (DENG)
Decision date: 2012-02-15
Date received: 2012-01-12
Classification advisory: Immunology
Review advisory: Immunology
Type: Post-NSE

Current FDA Classification#

Primary DI, Device, Company table
Primary DI	Device	Company	Published
07333066019833	ImmunoCAP Tryptase Control	Phadia AB	2019-03-28
07333066000350	ImmunoCAP Tryptase Control	Phadia AB	2019-03-28
07333066011998	ImmunoCAP Tryptase Curve Control 1	Phadia AB	2019-02-15
07333066000275	ImmunoCAP Tryptase Curve Control 1	Phadia AB	2019-02-15
07333066011592	ImmunoCAP Tryptase Calibrator Strip	Phadia AB	2016-09-23
07333066011622	ImmunoCAP Tryptase Curve Control Strip	Phadia AB	2016-09-23
07333066004082	ImmunoCAP Tryptase Anti-Tryptase	Phadia AB	2016-09-23
07333066000251	ImmunoCAP Tryptase Calibrator Strip	Phadia AB	2016-09-23
07333066000312	ImmunoCAP Tryptase Curve Control Strip	Phadia AB	2016-09-23