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Dako Logistics Company ApS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30130596833013059683Dako Logistics Company ApS1N2020-04-2542 PRODUKTIONSVEJ -- GLOSTRUP DK DK-2600

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2309271096459163P980018DAKO HERCEPTESTMVC1998-09-25
2309272020266277P150013PD-L1 IHC 22C3 PHARMDXPLS2015-10-02
2309271988166467P040005DAKOCYTOMATION HER2 FISH PHARMDX KITMVD2005-05-03
2309271469930849K991454MOUSE IGG1 NEGATIVE CONTROLSGKZ1999-06-21
2309271149814293K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1GKZ1999-06-21
2309271978063922K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37GKZ1998-07-22
2309272010723569K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEGKZ1997-06-24
2309271633845650K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEGKZ1996-05-17
2309271816987407K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEGKZ1996-06-14
2309271093767251K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/GKZ1996-01-26
2309271921434647K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25GKZ1994-11-21
2309271727241942K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLGKZ1994-11-21
2309271940599156K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELLGKZ1994-11-10
2309271009794559K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYDEH1995-04-20
2309271546391054K831909RABBIT ANTISERUM TO HUMAN IGACZN1983-07-18
2309271053461451K831908RABBIT ANTISERUM TO HUMAN IGGDGK1983-07-18
2309272012365031K831907RABBIT ANTISERUM TO HUMAN IGMDFS1983-07-19
2309271672435095K831906RABBIT ANTISERUM TO HUMAN C4DBI1983-07-19
2309271798203834K831905RABBITT ANTISERUM TO HUMAN C3CCZW1983-07-18
2309271881265955K831904RABBIT ANTISERUM TO HUMAN KAPPA LIGHTDEO1983-07-19
2309271133995698K831903FLUORESCEIN CONJUGATED IMMUNOGLOBULINDES1983-07-19
2309271419908806K831902FLUORESCEIN CONJUGATED IMMUNOGLOBIN-DDZ1983-07-18
2309271179154956K812662IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDADEH1981-09-29
2309271470469399K812661IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPADFH1981-09-29
2309271786834201K812495IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADEW1981-09-23
2309271104159323K812489IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGGDEW1981-09-23
2309271936952340K812488IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGACZP1981-09-23
2309271967631211K812487IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGMDAO1981-09-23
2309271402099505K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)MXZ2013-12-09
2309271349533719K120663MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPIMYA2013-02-12
2309271618722967K042884DAKOCYTOMATION ER/PR PHARMDX KITMXZ2005-02-15
2309271737491791K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORNDY2004-09-03
2309271485778360K032692DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368JZG2004-01-22
2309271658671774K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGMXZ2002-02-28
2309271068501444
2309271130233038
2309271143532930
2309271191195238
2309271287783166
2309271340911345
2309271351231362
2309271368599224
2309271371057551
2309271451403817
2309271458742889
2309271467385891
2309271467628315
2309271517923035
2309271521122269
2309271526880409
2309271529506661
2309271531184567
2309271552932253
2309271559266910
2309271565023469
2309271575632001
2309271605358678
2309271614820174
2309271768405086
2309271773586951
2309271891567786
2309271895293542
2309271899205818
2309271901295832
2309271937254655
2309271949569213
2309271956288166
2309272018555278
2309272037900304
2309272051024050

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ101999-06-21
MXZ32013-12-09
DEH21995-04-20
DEW21981-09-23
PLS12015-10-02
MYA12013-02-12
MVD12005-05-03
NDY12004-09-03
JZG12004-01-22
MVC11998-09-25
DEO11983-07-19
DES11983-07-19
DFS11983-07-19
DBI11983-07-19
CZN11983-07-18
DGK11983-07-18
CZW11983-07-18
DDZ11983-07-18
DFH11981-09-29
DAO11981-09-23
CZP11981-09-23