FDA.reportPublic FDA data

Danial Kirmani

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80323143002808140Danial Kirmani1N2026-01-01Dept. Rx51/J55/Ms 6134 100 Abbott Park Rd North Chicago IL US 60064
96130693003045237Danial Kirmani1N2026-01-01150 S. Saunders Road Landmark of Lake Forest Lake Forest IL US 60045

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
414791294174345K980907AXIS HOMOCYSTEINE ENZYME IMMUNOASSAYLPS1998-10-16
414791940513027K253539Alere NT-proBNP for Alinity iNBC2026-02-18
414791791829979K241176Alere NT-proBNP for Alinity i Reagent KitNBC2025-01-16
414791828201919K233541ARCHITECT Active-B12 (Holotranscobalamin)CDD2024-07-31
3469621719554644K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerLCP2023-09-27
3469621956337964K182988Afinion HbA1c Dx on Afinion 2PDJ2018-11-29
3469621997420994K180296Afinion HbA1c DxPDJ2018-05-07
3469621261552122K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerLCP2017-11-21
3469621891886659K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerLCP2015-09-25
3469621078538992K132031AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROLCHH2014-03-21
414791520352850K121946AXIS-SHIELD ACVTIVE-B12CDD2013-03-22
414791831333985K121842ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CLCP2012-12-12
414791836290259K112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONLPS2012-05-07
414791027531526K112443ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)CDD2011-12-19
414791806413817K110296AXIS-SHIELD ANTI-CCPNHX2011-08-18
3469621398838987K110056AFINION ANALYZERLCP2011-02-15
414792003894202K083868ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35NHX2009-09-25
414791627646445K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100LPS2009-07-31
414791181795070K073640ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLSLPS2008-04-24
414791160253374
414791172589760
414791205085546
414791345974046
414791371997126
414791475144966
414791487583416
414791495444487
414791602971854
414791633019240
414791642289167
414791711237656
414791738848100
414791892310384
414791966272308
414792061921327

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCP52023-09-27
LPS42012-05-07
CDD32024-07-31
NBC22026-02-18
PDJ22018-11-29
NHX22011-08-18
CHH12014-03-21