FDA.reportPublic FDA data

AGILE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12174541217454Agilent Technologies, Inc.1N2026-01-01100 Tigan St Highland Park, PO Box 998 Winooski VT US 05404
20221802022180Agilent Technologies, Inc.1N2026-01-016392 VIA REAL CARPINTERIA CA US 93013
29162052916205Agilent Technologies, Inc1Y2026-01-015301 Stevens Creek Blvd Santa Clara CA US 95051
96100993002806778Agilent Technologies Denmark ApS1N2026-01-0142 PRODUKTIONSVEJ GLOSTRUP Hovedstaden DK DK-2600
30034238693003423869Agilent Technologies Singapore (International) Pte Ltd.1N2026-01-01Agilent Technologies No.1 Yishun Avenue 7 Singapore North East SG 768923
30091898933009189893Agilent Technologies Inc.1N2026-01-011834 State Highway 71 West Cedar Creek TX US 78612
30092024673009202467Agilent Technologies1N2026-01-01Hewlett-Packard-Strasse 8 Waldbronn Baden-Wurttemberg DE BW 76337
30122607833012260783Agilent Technologies Memphis1Y2026-01-015050 East Holmes Road Suite 105 MPHS TN US 38141
30231672833023167283AGILE DEVICES, INC.1N2026-01-011087 Beacon Street Suite 302 Newton Centre MA US 02459
30318230693031823069AGILEMD1N2026-01-0110080 N. Wolfe Rd., Suite SW3-229 Cupertino CA US 95014
30089903303008990330AGILE EYEWEAR MFG. CO.1N2020-04-25No. 14 Yuan Hu Road, Zhang Bei Industrial Zone, Long Gang District Shenzhen Guangdong CN 517172
30091898933009189893Agilent Technologies Inc.1N2020-04-251834 State Highway 71 West Cedar Creek TX US 78612
30117527403011752740AGILE MV1N2020-04-253700 rue Saint-Patrick suite 102 Montreal Quebec CA H4E 1A2

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05700572005322Mono Mo A-Hu Serotonin Cl 5HT-H209 - Monoclonal Mouse Anti-Human Serotonin Clone 5HT-H209+4544859500dako.dkregulatory@agilent.com
05700572005322Mono Mo A-Hu Serotonin Cl 5HT-H209 - Monoclonal Mouse Anti-Human Serotonin Clone 5HT-H209+1-800-227-9770Global.RA@agilent.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1353591335552441P980018DAKO HERCEPTESTMVC1998-09-25
2788601335552441P980018DAKO HERCEPTESTMVC1998-09-25
2993121335552441P980018DAKO HERCEPTESTMVC1998-09-25
1505721331316884P250004MMR IHC Panel pharmDx (Dako Omnis)QNH2025-08-15
2788201331316884P250004MMR IHC Panel pharmDx (Dako Omnis)QNH2025-08-15
2993121331316884P250004MMR IHC Panel pharmDx (Dako Omnis)QNH2025-08-15
1505721513821395P230016MAGE-A4 IHC 1F9 pharmDxSBL2024-08-01
2788201513821395P230016MAGE-A4 IHC 1F9 pharmDxSBL2024-08-01
2993121513821395P230016MAGE-A4 IHC 1F9 pharmDxSBL2024-08-01
1505721807928927P210026Ki-67 IHC pharmDxQQT2021-10-12
2788201807928927P210026Ki-67 IHC pharmDxQQT2021-10-12
2993121807928927P210026Ki-67 IHC pharmDxQQT2021-10-12
1505721897445323P150025PD-L1 IHC 28-8 pharmDx2015-10-09
2788201897445323P150025PD-L1 IHC 28-8 pharmDx2015-10-09
2993121897445323P150025PD-L1 IHC 28-8 pharmDx2015-10-09
1505721900722000P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
2788201900722000P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
2993121900722000P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
1353591746834183P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD2005-05-03
2788601746834183P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD2005-05-03
2993121746834183P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD2005-05-03
1353591214320381K991454MOUSE IGG1 NEGATIVE CONTROLSGKZ1999-06-21
2788601214320381K991454MOUSE IGG1 NEGATIVE CONTROLSGKZ1999-06-21
2993121214320381K991454MOUSE IGG1 NEGATIVE CONTROLSGKZ1999-06-21
1353591696224825K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZ1999-06-21
2788601696224825K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZ1999-06-21
2993121696224825K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZ1999-06-21
1353591445347453K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZ1998-07-22
2788601445347453K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZ1998-07-22
2993121445347453K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZ1998-07-22
1353591263868670K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZ1997-06-24
2788601263868670K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZ1997-06-24
2993121263868670K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZ1997-06-24
1353591953107991K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZ1996-05-17
2788601953107991K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZ1996-05-17
2993121953107991K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZ1996-05-17
1353591807249593K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZ1996-06-14
2788601807249593K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZ1996-06-14
2993121807249593K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZ1996-06-14
1353591851252516K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZ1996-01-26
2788601851252516K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZ1996-01-26
2993121851252516K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZ1996-01-26
1353591893668242K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZ1994-11-21
2788601893668242K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZ1994-11-21
2993121893668242K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZ1994-11-21
1353591118679556K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZ1994-11-21
2788601118679556K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZ1994-11-21
2993121118679556K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZ1994-11-21
1353591189197481K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZ1994-11-10
2788601189197481K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZ1994-11-10
2993121189197481K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZ1994-11-10
1353591301762624K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEH1995-04-20
2788601301762624K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEH1995-04-20
2993121301762624K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEH1995-04-20
1353591099778735K831909RABBIT ANTISERUM TO HUMAN IGACZN1983-07-18
2788601099778735K831909RABBIT ANTISERUM TO HUMAN IGACZN1983-07-18
2993121099778735K831909RABBIT ANTISERUM TO HUMAN IGACZN1983-07-18
1353591831254096K831908RABBIT ANTISERUM TO HUMAN IGGDGK1983-07-18
2788601831254096K831908RABBIT ANTISERUM TO HUMAN IGGDGK1983-07-18
2993121831254096K831908RABBIT ANTISERUM TO HUMAN IGGDGK1983-07-18
1353591768381684K831907RABBIT ANTISERUM TO HUMAN IGMDFS1983-07-19
2788601768381684K831907RABBIT ANTISERUM TO HUMAN IGMDFS1983-07-19
2993121768381684K831907RABBIT ANTISERUM TO HUMAN IGMDFS1983-07-19
1353591853923574K831906RABBIT ANTISERUM TO HUMAN C4DBI1983-07-19
2788601853923574K831906RABBIT ANTISERUM TO HUMAN C4DBI1983-07-19
2993121853923574K831906RABBIT ANTISERUM TO HUMAN C4DBI1983-07-19
1353591337230154K831905RABBITT ANTISERUM TO HUMAN C3CCZW1983-07-18
2788601337230154K831905RABBITT ANTISERUM TO HUMAN C3CCZW1983-07-18
2993121337230154K831905RABBITT ANTISERUM TO HUMAN C3CCZW1983-07-18
1353591225883248K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEO1983-07-19
2788601225883248K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEO1983-07-19
2993121225883248K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEO1983-07-19
1353591738306062K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDES1983-07-19
2788601738306062K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDES1983-07-19
2993121738306062K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDES1983-07-19
1353591815943114K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZ1983-07-18
2788601815943114K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZ1983-07-18
2993121815943114K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZ1983-07-18
1353591167577867K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEH1981-09-29
2788601167577867K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEH1981-09-29
2993121167577867K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEH1981-09-29
1353591158496313K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFH1981-09-29
2788601158496313K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFH1981-09-29
2993121158496313K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFH1981-09-29
1353591319601833K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEW1981-09-23
2788601319601833K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEW1981-09-23
2993121319601833K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEW1981-09-23
1353591102170970K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEW1981-09-23
2788601102170970K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEW1981-09-23
2993121102170970K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEW1981-09-23
1353591111447006K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZP1981-09-23
2788601111447006K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZP1981-09-23
2993121111447006K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZP1981-09-23
1353591010974850K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAO1981-09-23
2788601010974850K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAO1981-09-23
2993121010974850K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAO1981-09-23
3305041006121306K233253eCARTv5 Clinical Deterioration Suite (“eCART”)QNL2024-06-21
3071141674897454K211110Agile Devices Angler Steerable, Deflectable MicrocatheterKRA2022-01-07
2183281513886384K171557AcQRef Introducer SheathDYB2018-02-06
1505721770798214K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA2017-12-21
2788201770798214K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA2017-12-21
2993121770798214K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA2017-12-21
1353591410636932K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
1505721410636932K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
2788201410636932K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
2788601410636932K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
2993121410636932K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
1505721272789053K163367GenetiSure Dx Postnatal AssayPFX2017-08-11
2993121272789053K163367GenetiSure Dx Postnatal AssayPFX2017-08-11
1301412007888516K163367GenetiSure Dx Postnatal AssayPFX2017-08-11
1505721527783934K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
2788201527783934K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
2993121527783934K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
1505721119620493K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
2788201119620493K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
2993121119620493K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
1505721059705213K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
2788201059705213K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
2993121059705213K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
1353591246391297K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORNDY2004-09-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ301999-06-21
MXZ142017-12-21
MYA62017-12-21
PLS62015-10-09
DEH61995-04-20
DEW61981-09-23
QQT 32021-10-12
PFX32017-08-11
MVD32005-05-03
NDY32004-09-03
JZG32004-01-22
MVC31998-09-25
DFS31983-07-19
DEO31983-07-19
DBI31983-07-19
DES31983-07-19
DGK31983-07-18
CZW31983-07-18
DDZ31983-07-18
CZN31983-07-18
DFH31981-09-29
DAO31981-09-23
CZP31981-09-23
QNL12024-06-21
KRA12022-01-07
DYB12018-02-06

NDC#

Twirla

Agile Therapeutics, Inc.

levonorgestrel/ethinyl estradiol

PMA#

PD-L1 IHC 22C3 pharmDx

2022-11-03

Agilent Technologies, Inc.5301 Stevens Creek Blvdsanta Clara, CA 95051 PMA NumberP150013 Supplement NumberS025 Date Received08/08/2022 Decision Date11/03/2022 Product Code PLS  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason ...

PD-L1 IHC 28-8 pharmDx

2022-07-22

Agilent Technologies, Inc.5301 Stevens Creek Blvdsanta Clara, CA 95051 PMA NumberP150025 Supplement NumberS015 Date Received06/17/2022 Decision Date07/22/2022 Product Code PLS  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Proc...

PMN#

47 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next