[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PCG":3},{"classification":4,"mappedDevices":36,"relatedClassifications":37,"syncDates":101},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":33},915,"PCG","21-Hydroxylase Antibody (21-Ohab)","2","866.5660","IM","Immunology","1","For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":27,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":27,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":17,"fei_number":20,"registration_number":25},[18,19],"K121046","K180607",[21,22,23,24],"2025560","3002808039","2245285","3002800697",[21,26,23,24],"3003834021","","N","Y","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,[],[38,42,46,50,54,58,62,66,70,73,76,79,82,85,89,92,95,98],{"product_code":39,"device_name":40,"device_class":8,"k510_count":41},"MID","System, Test, Anticardiolipin Immunological",94,{"product_code":43,"device_name":44,"device_class":8,"k510_count":45},"MOB","Test System, Antineutrophil Cytoplasmic Antibodies (Anca)",74,{"product_code":47,"device_name":48,"device_class":8,"k510_count":49},"MSV","System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)",46,{"product_code":51,"device_name":52,"device_class":8,"k510_count":53},"MVM","Autoantibodies, Endomysial(Tissue Transglutaminase)",40,{"product_code":55,"device_name":56,"device_class":8,"k510_count":57},"DBL","Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control",24,{"product_code":59,"device_name":60,"device_class":8,"k510_count":61},"MVJ","Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)",6,{"product_code":63,"device_name":64,"device_class":8,"k510_count":65},"NST","Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking",4,{"product_code":67,"device_name":68,"device_class":8,"k510_count":69},"NBS","Autoantibodies, Lkm-1 (Liver\u002FKidney Microsome, Type 1)",3,{"product_code":71,"device_name":72,"device_class":8,"k510_count":69},"NIY","Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis",{"product_code":74,"device_name":75,"device_class":8,"k510_count":69},"OEG","Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230",{"product_code":77,"device_name":78,"device_class":8,"k510_count":69},"OIF","Tyrosine Phosphatase (Ia-2) Autoantibody Assay",{"product_code":80,"device_name":81,"device_class":8,"k510_count":35},"NBO","Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)",{"product_code":83,"device_name":84,"device_class":8,"k510_count":35},"NWG","Autoantibodies, Glutamic Acid Decarboxylase (Gad)",{"product_code":86,"device_name":87,"device_class":8,"k510_count":88},"MVS","Kit, Typing, Hla-Dqb",1,{"product_code":90,"device_name":91,"device_class":8,"k510_count":88},"OCN","Insulin Autoantibody Kit",{"product_code":93,"device_name":94,"device_class":8,"k510_count":88},"OPN","Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine\u002FProthrombin Complex",{"product_code":96,"device_name":97,"device_class":8,"k510_count":88},"OSK","Anti-Glutamate Receptor (Type Nmda) Ifa",{"product_code":99,"device_name":100,"device_class":8,"k510_count":88},"PAF","Voltage Gated  Calcium Channel (Vgcc) Antibody Assay",{"510k":102,"classification":103,"enforcement":104,"event":105,"pma":106,"warning_letter":107},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]