FDA.reportPublic FDA data

Agilent Technologies Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091898933009189893Agilent Technologies Inc.1N2026-01-011834 State Highway 71 West Cedar Creek TX US 78612
30091898933009189893Agilent Technologies Inc.1N2020-04-251834 State Highway 71 West Cedar Creek TX US 78612

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2993121335552441P980018DAKO HERCEPTESTMVC1998-09-25
2993121331316884P250004MMR IHC Panel pharmDx (Dako Omnis)QNH2025-08-15
2993121513821395P230016MAGE-A4 IHC 1F9 pharmDxSBL2024-08-01
2993121807928927P210026Ki-67 IHC pharmDxQQT2021-10-12
2993121897445323P150025PD-L1 IHC 28-8 pharmDx2015-10-09
2993121900722000P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
2993121746834183P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD2005-05-03
2993121214320381K991454MOUSE IGG1 NEGATIVE CONTROLSGKZ1999-06-21
2993121696224825K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZ1999-06-21
2993121445347453K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZ1998-07-22
2993121263868670K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZ1997-06-24
2993121953107991K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZ1996-05-17
2993121807249593K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZ1996-06-14
2993121851252516K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZ1996-01-26
2993121893668242K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZ1994-11-21
2993121118679556K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZ1994-11-21
2993121189197481K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZ1994-11-10
2993121301762624K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEH1995-04-20
2993121099778735K831909RABBIT ANTISERUM TO HUMAN IGACZN1983-07-18
2993121831254096K831908RABBIT ANTISERUM TO HUMAN IGGDGK1983-07-18
2993121768381684K831907RABBIT ANTISERUM TO HUMAN IGMDFS1983-07-19
2993121853923574K831906RABBIT ANTISERUM TO HUMAN C4DBI1983-07-19
2993121337230154K831905RABBITT ANTISERUM TO HUMAN C3CCZW1983-07-18
2993121225883248K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEO1983-07-19
2993121738306062K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDES1983-07-19
2993121815943114K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZ1983-07-18
2993121167577867K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEH1981-09-29
2993121158496313K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFH1981-09-29
2993121319601833K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEW1981-09-23
2993121102170970K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEW1981-09-23
2993121111447006K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZP1981-09-23
2993121010974850K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAO1981-09-23
2993121770798214K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA2017-12-21
2993121410636932K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
2993121272789053K163367GenetiSure Dx Postnatal AssayPFX2017-08-11
1301412007888516K163367GenetiSure Dx Postnatal AssayPFX2017-08-11
2993121527783934K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
2993121119620493K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
2993121059705213K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
2993121246391297K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORNDY2004-09-03
2993121111338703K032692DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368JZG2004-01-22
2993121627488190K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGMXZ2002-02-28
1301411256541300
1301411386456021
2993121002646485
2993121067762266
2993121075647692
2993121110972476
2993121142230799
2993121146122900
2993121181674914
2993121201275694
2993121215803257
2993121216560212
2993121257793252
2993121304806037
2993121309927850
2993121313438023
2993121389419038
2993121402276810
2993121412748579
2993121472002432
2993121482555657
2993121486096455
2993121521957324
2993121550794870
2993121579488418
2993121608547904
2993121623174605
2993121639607475
2993121651613299
2993121689426650
2993121725520078
2993121752069715
2993121788411395
2993121806806026
2993121809175872
2993121859284327
2993121861817911
2993121865585230
2993121931466733
2993121956102014
2993121974263604
2993122005256413
2993122031618655
2993122041802783
2993122052112489

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ101999-06-21
MXZ42017-12-21
MYA22017-12-21
PFX22017-08-11
PLS22015-10-09
DEH21995-04-20
DEW21981-09-23
QQT 12021-10-12
MVD12005-05-03
NDY12004-09-03
JZG12004-01-22
MVC11998-09-25
DBI11983-07-19
DEO11983-07-19
DES11983-07-19
DFS11983-07-19
CZN11983-07-18
DGK11983-07-18
DDZ11983-07-18
CZW11983-07-18
DFH11981-09-29
DAO11981-09-23
CZP11981-09-23