Radioimmunoassay, Immunoglobulins (D, E)

FDA product code JHR · Class II (moderate risk) · 21 CFR 866.5510 · Immunology

9510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K061970Elecsys Ige II ImmunoassayJHR · Special Roche Diagnostics08/31/2006SE
K984326Elecys Ige AssayJHR · Traditional Boehringer Mannheim Corp.02/08/1999SE
K960067Immilite Total IgeJHR · Traditional Diagnostic Products Corp.02/14/1996SE
K931703Immulite Total IgeJHR · Traditional Diagnostic Products Corp.08/16/1993SE
K903000Turbo-Rast Specific Ige AssayJHR · Traditional Ventrex Laboratories, Inc.07/31/1990SE
K901859Coat-A-Count Total Ige Irma, Catalog #IKIE1, IKIE2JHR · Traditional Diagnostic Products Corp.05/03/1990SE
K882616Alternate Procedure, Pharmacia Ige EiaJHR · Traditional Pharmacia, Inc.08/04/1988SE
K873077Pharmacia Ige EiaJHR · Traditional Pharmacia, Inc.10/20/1987SE
K840103Radioimmunoassay for Total Ige HumanJHR · Traditional Techniclone Intl.02/10/1984SE

Recalls

RecallProductFirmInitiated
Z-1518-2014 Class IIIMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and…Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE… Siemens Healthcare Diagnostics12/20/2013Terminated
Z-1517-2014 Class IIIMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens…Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE… Siemens Healthcare Diagnostics12/20/2013Terminated