PMA P820060S013

Device: ABBOTT ARCHITECHT AFP
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S013
Product code: LOJ
Decision date: 2004-02-02
Classification: Immunology
Generic name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Approval order statement: APPROVAL FOR THE ADDITION OF THE AFP ASSAY ON THE ARCHITECT IMMUNOASSAY INSTRUMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT AFP ASSAY AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN : 1) HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOSUS TESTICULAR CANCER. 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (NTD).

Current openFDA PMA Record#

Device: ABBOTT ARCHITECHT AFP
Applicant: Abbott Laboratories
PMA number: P820060
Supplement: S013
Product code: LOJ
Generic name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Decision date: 2004-02-02
Decision code: APPR
Date received: 1999-07-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF THE AFP ASSAY ON THE ARCHITECT IMMUNOASSAY INSTRUMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT AFP ASSAY AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN : 1) HUMAN SERUM OR PLASMA TO AID IN THE MANAGEMENT OF PATIENTS WITH NONSEMINOMATOSUS TESTICULAR CANCER. 2) HUMAN SERUM, PLASMA, AND AMNIOTIC FLUID AT 15 TO 21 WEEKS GESTATION TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (NTD).