Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MiscellaneousMiscellaneous
- OYMProstrate Cancer Genes Nucleic Acid Amplification Test System3Product Code
- KTJSystem, Test, Alpha-Fetoprotein, Ria3Product Code
- LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects3Product Code
- P120008ABBOTT ARCHITECT AFP ASSAYAPPRPMA Approval
- P010007IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPAPPRPMA Approval
- P980041ACCESS AFP IMMUNOASSAY SYSTEMAPPRPMA Approval
- P970037AUTODELFIA HAFP TEST KITAPPRPMA Approval
- P930036ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSAPPRPMA Approval
- P790032GAMMA DAB (125I) AFP RIA KITAPWDPMA Approval
- P780005ABBOTT AFPAPWDPMA Approval
- P780006AMERSHAM AFPAPWDPMA Approval
- P800025QUANTITOPE 125I AFP KIT AND CONTROL SERUMAPWDPMA Approval
- P760001AFP RIA KITAPWDPMA Approval
- P980041Access AFP Reagents on the Access Immunoassay System3PMA Approval
- P980041Access AFP Reagents on the Access Immunoassay Systems3PMA Approval
- P010007IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 AFP3PMA Approval
- P930036ADVIA Centaur AFP Readypack Reagents3PMA Approval
- P010007IMMULITE/IMMULITE 1000/IMMULITE 2000 AFP3PMA Approval
- P930036Advia Centaur AFP Immunoassay and Atellica IM AFP Immunoassay3PMA Approval
- P120008Alinity i AFP Reagent Kit3PMA Approval
- P980041Acess AFP Reagents on the Access Immunoassay Systems3PMA Approval
- P120008ARCHITECT AFP3PMA Approval
- P120008Alinity i AFP3PMA Approval
- P930036Atellica IM Alpha Fetoprotien (AFP) Assay3PMA Approval
- P930036ADVIA Centaur and Atellica IM AFP3PMA Approval
- P980041Access AFP Reagents on the Access Immunoassay Systems3PMA Approval
- P010007IMMULITE 2000 AFP3PMA Approval
- P980041Access AFP Reagents on the Access Immunoassay Systems3PMA Approval
- P980041Access AFP Reagents on the Access Immunoassay Systems3PMA Approval
- P120008Alinity i AFP Assay3PMA Approval
- P930036Atellica IM Alpha Fetoprotein (AFP) Assay3PMA Approval
- P930036Atellica IM Alpha Fetoprotein (AFP)3PMA Approval
- P010007IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP3PMA Approval
- P980041Acess AFP Reagents on the Access Immunoassay Systems3PMA Approval
- P120008ARCHITECT AFP assay3PMA Approval
- P930036Atellica IM Alpha Fetoprotein (AFP)3PMA Approval
- P980041Access AFP Reagents on the Access Immunoassay Systems3PMA Approval
- P970037AutoDELFIA hAFP Test Kit3PMA Approval
- P930036Atellica IM Alpha Fetoprotein (AFP)3PMA Approval
- P930036ADVIA CENTAUR AFP ASSAY3PMA Approval
- P980041Access AFP Immunoassay3PMA Approval
- P980041Access AFP Reagents on the Access Immunoassy Systems3PMA Approval
- P980041Access AFP Reagents on the Access Immunoassay Systems3PMA Approval
- P970037AutoDELFIA hAFP Test System3PMA Approval
- P930036ADVIA CENTAUR IMMUNOASSAY3PMA Approval
- P980041ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P120008ABBOTT ARCHITECT AFP ASSAY3PMA Approval
- P970037AUTODELFIA HAFP TEST SYSTEM3PMA Approval
- P120008ARCHITECT AFP (LN 3P36)3PMA Approval
- P120008ARCHITECT AFP ASSAY (LN 3P36)3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP IMMUNOASSAY SYSTEM3PMA Approval
- P980041ACCESS AFP IMMUNOASSAY SYSTEM3PMA Approval
- P120008ARCHITECT AFP3PMA Approval
- P980041ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P120008ARCHITECT AFP3PMA Approval
- P120008ARCHITECT AFP3PMA Approval
- P120008ARCHITECT AFP3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P120008ARCHITECT AFP ASSAY3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P120008ARCHITECT AFP,LN 3P363PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P120008ARCHITECT AFP3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P820060AXSYM AFP3PMA Approval
- P120008ABBOTT ARCHITECT AFP ASSAY3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P010007IMMULITE AFP ASSAY3PMA Approval
- P930036ADVIA CENTAUR AFP ASSAY3PMA Approval
- P930036ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS3PMA Approval
- P970037AUTODELFIA HAFP TEST SYSTEM3PMA Approval
- P970037AUOTDELFIA HAFP KIT3PMA Approval
- P980041ACCESS AFB REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P010007AFP IMMULITE SUBSTRATE REAGENT3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P820060AXSYM AFP (LN 7A48)3PMA Approval
- P010007IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP3PMA Approval
- P010007AFP IMMULITE ASSAY3PMA Approval
- P980041ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P970037AUTODELFIA / DELFIA XPRESS HAFP TEST SYSTEM3PMA Approval
- P820060AXSYM AFP3PMA Approval
- P820060AXSYM AFP3PMA Approval
- P820060ABBOTT AXSYM AFP3PMA Approval
- P010007IMMULITE/IMMULITE 2000 AFP3PMA Approval
- P970037AUTODELFIA HAFP KIT3PMA Approval
- P970037AUTODELFIA/DELFIA XPRESS HAFP3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P970037AUTODELFIA XPRESS HAFP TEST SYSTEM3PMA Approval
- P820060AXSYM AFP (LN 7A48)3PMA Approval
- P820060ABBOTT AFP-EIA3PMA Approval
- P010007IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 AFP3PMA Approval
- P970037AUTODELFIA HAFP KIT3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER3PMA Approval
- P820060ABBOTT ARCHITECT AFP3PMA Approval
- P980041ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P820060ABBOTT AXSYM AFP3PMA Approval
- P980041IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P820060ABBOTT AFP-EIA DIAGNOSTIC KIT3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS3PMA Approval
- P930036ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER3PMA Approval
- P010007IMMULITE 2500 AFP, MODEL L5KAP3PMA Approval
- P010007IMMULITE AFP AND IMMULITE 2000 AFP3PMA Approval
- P980041ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM3PMA Approval
- P980041ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM3PMA Approval
- P970037AUTODELFIA HAFP TEST KIT3PMA Approval
- P980041ACCESS AFP ASSAY ON THE ACCESS 2 IMMUNOASSAY SYSTEMS3PMA Approval
- P930036ACS:180/ADVIA CENTAUR AFP IMMUNOASSAY3PMA Approval
- P010007IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP3PMA Approval
- P980041ACCESS AFP IMMUNOASSAY SYSTEM3PMA Approval
- P930036ACS: CENTAUR AFP IMMUNOASSAY3PMA Approval
- P970037AUTODELFIA HAFP TEST KIT3PMA Approval
- P800025QUANTITOPE 125I AFP KIT AND CONTROL SERUM3PMA Approval
- P930036ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS3PMA Approval
- P790032CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]3PMA Approval
- P790032CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]3PMA Approval
- P780006AMERSHAM AFP3PMA Approval
- P800025QUANTITOPE 125I AFP KIT AND CONTROL SERUM3PMA Approval
- P790032GAMMA DAB (125I) AFP RIA KIT3PMA Approval
- P790032GAMMA DAB (125I) AFP RIA KIT3PMA Approval
- P780006AMERSHAM AFP3PMA Approval
- P800025QUANTITOPE 125I AFP KIT AND CONTROL SERUM3PMA Approval
- P780005ABBOTT AFP3PMA Approval
- P780005ABBOTT AFP3PMA Approval
- P780006AMERSHAM AFP3PMA Approval
- P760001AFP RIA KIT3PMA Approval
- P800025AFP/OB(TM) RIA KIT3PMA Approval
- P800025QUANTITOPE 125I AFP KIT AND CONTROL SERUM3PMA Approval
- P760001AFP RIA KIT3PMA Approval
- P820060ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER3PMA Approval
- LTQCalibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum3Product Code
- MANAssay, Interleukin3Product Code
- MJBAntigen, Cancer 5493Product Code
- MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer3Product Code
- MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions3Product Code
- MYZKit, Test (Donors), For Bloodborne Pathogen2Product Code
- MZATest, Equipment, Automated Bloodborne PathogenNProduct Code
- MZETest, Donor, Cmv2Product Code
- MZFTest, Hiv Detection3Product Code
- MZLKit, Test, Quality Control For EndotoxinNProduct Code
- NAFAntigen(Complexed),Prostate Specific,(Cpsa)3Product Code
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer3Product Code
- NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer3Product Code
- OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic MesotheliomaFProduct Code
- OCBRt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection3Product Code
- OTRResearch Use Only/Immunology DevicesNProduct Code
- OWDSomatic Gene Mutation Detection System3Product Code
- OYAP2psa3Product Code
- OYYLeukemia Translocation Panel Multiplex TestNProduct Code
- PILTest For Periprosthetic Joint InfectionNProduct Code
- QLCInterleukin 6NProduct Code
- QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer3Product Code
- QSEAlzheimer’S Disease Pathology Assessment Test2Product Code
- QWQAssays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors3Product Code
- SADJapanese Encephalitis Virus Immunological/Serology TestNProduct Code
- SETImmunoassay Blood Test For Amyloid Pathology Assessment2Product Code
- SFCNeurologic Disease Risk Assessment Molecular Test2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AXSYM AFP
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Abbott Laboratories
- Trade Name
- ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER
- Generic Name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision Date
- 6/21/1983
- Days to Decision
- 312 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval