FDA.report

DAKO DENMARK ApS

Matched from indexed company URL: Dako Denmark ApS

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96100993002806778DAKO DENMARK ApS1N2020-04-2542 PRODUKTIONSVEJ GLOSTRUP Region Hovedstaden DK DK-2600

GUDID Contact Samples

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

Source GUDIDProductPhoneEmail
05700571106938FLEX Mono Rb A-Hu Cyclin D1, Cl EP12, RTU (Dako Omnis) - FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (Dako Omnis)+4544859500dako.dkregulatory@agilent.com
05700571107034FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Dako Omnis) - FLEX Monoclonal Mouse Anti-Human Mammaglobin Clone 304-1A5 Ready-to-Use (Dako Omnis)+4544859500dako.dkregulatory@agilent.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
132211096459163P980018DAKO HERCEPTESTMVC1998-09-25
132211899769849P150025PD-L1 IHC 28-8 pharmDx2015-10-09
132212020266277P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
132211988166467P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD2005-05-03
132211624158755P030044DAKOCYTOMATION EGFR PHARMDXNQF2004-02-12
132211469930849K991454MOUSE IGG1 NEGATIVE CONTROLSGKZ1999-06-21
132211149814293K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZ1999-06-21
132211111735081K984188AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)JOY1999-07-28
132211978063922K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZ1998-07-22
132212010723569K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZ1997-06-24
132211633845650K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZ1996-05-17
132211816987407K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZ1996-06-14
132211093767251K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZ1996-01-26
132211921434647K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZ1994-11-21
132211727241942K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZ1994-11-21
132211940599156K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZ1994-11-10
132211009794559K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEH1995-04-20
132211546391054K831909RABBIT ANTISERUM TO HUMAN IGACZN1983-07-18
132211053461451K831908RABBIT ANTISERUM TO HUMAN IGGDGK1983-07-18
132212012365031K831907RABBIT ANTISERUM TO HUMAN IGMDFS1983-07-19
132211672435095K831906RABBIT ANTISERUM TO HUMAN C4DBI1983-07-19
132211798203834K831905RABBITT ANTISERUM TO HUMAN C3CCZW1983-07-18
132211881265955K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEO1983-07-19
132211133995698K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDES1983-07-19
132211419908806K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZ1983-07-18
132211179154956K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEH1981-09-29
132211470469399K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFH1981-09-29
132211786834201K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEW1981-09-23
132211104159323K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEW1981-09-23
132211936952340K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZP1981-09-23
132211967631211K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAO1981-09-23
132211158874605K170028FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA2017-12-21
132211386555872K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)MXZ2017-12-21
132211402099505K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
132211349533719K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
132211618722967K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
132211737491791K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORNDY2004-09-03
132211485778360K032692DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368JZG2004-01-22
132211411526028K032113ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)NOT2003-12-23
132211658671774K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGMXZ2002-02-28
132211033313466
132211067474226
132211068501444
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132211191195238
132211210967490
132211249787114
132211287783166
132211340911345
132211351231362
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132211368599224
132211371057551
132211377051165
132211413581631
132211433066984
132211451403817
132211456624308
132211458742889
132211467385891
132211467628315
132211470112281
132211517923035
132211521122269
132211526880409
132211529506661
132211531184567
132211540008035
132211552932253
132211559266910
132211565023469
132211575632001
132211599811939
132211605358678
132211614820174
132211644422591
132211714376086
132211734240456
132211757690793
132211765068120
132211768405086
132211773586951
132211826540424
132211891567786
132211894018312
132211895293542
132211899205818
132211901295832
132211937254655
132211949569213
132211953278865
132211956288166
132211958152101
132212003502626
132212018555278
132212037900304
132212051024050

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GKZ101999-06-21
MXZ42017-12-21
MYA22017-12-21
PLS22015-10-09
DEH21995-04-20
DEW21981-09-23
MVD12005-05-03
NDY12004-09-03
NQF12004-02-12
JZG12004-01-22
NOT12003-12-23
JOY11999-07-28
MVC11998-09-25
DEO11983-07-19
DFS11983-07-19
DES11983-07-19
DBI11983-07-19
DDZ11983-07-18
CZW11983-07-18
DGK11983-07-18
CZN11983-07-18
DFH11981-09-29
CZP11981-09-23
DAO11981-09-23

PMA

GUDID

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