Data / Medical devices / Denmark / ATSI Logistics Center ApS

ATSI Logistics Center ApS: FDA-registered device maker in GLOSTRUP Hovedstaden, Denmark, 28 510(k) clearances and 2 PMA approvals

Name: ATSI Logistics Center ApS FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ATSI Logistics Center ApS is registered with the FDA (registration 3013059683) in GLOSTRUP Hovedstaden, Denmark. It lists 37 device types. The FDA files 28 510(k) clearances and 2 PMA approvals under its listings, the newest dated December 21, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013059683
Address: 42 Produktionsvej --, GLOSTRUP Hovedstaden, Denmark, DK-2600
Owner or operator: Agilent Technologies, Inc (10038794)
Roles: Exporter to the US
First device listed: November 25, 2014
Registered through: 2026
Brand names listed: 28S rRNA CISH Probe, ACIS III Tissue Micro-Array Application Software, ADVANCE HRP, AEC Substrate-Chromogen, Ready-to-Use, AEC+ High Sensitivity Substrate Chromogen, Ready-to-Use, AEC+ Substrate-Chromogen, Ready-to-Use, ALK FISH DNA Probe, Split Signal, ARK (Animal Research Kit)/HRP and more

Devices it lists

Device	Product code	Class	Role	Source
Albumin, Fitc, Antigen, Antiserum, Control	DDZ	2	Exporter to the US	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Exporter to the US	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Exporter to the US	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Exporter to the US	accessdata.fda.gov
Counter, Differential Cell	GKZ	2	Exporter to the US	accessdata.fda.gov
Coverslips, Microscope Slide	KES	1	Exporter to the US	accessdata.fda.gov
Eosin Y	HYB	1	Exporter to the US	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Exporter to the US	accessdata.fda.gov
General Purpose Reagent	PPM	1	Exporter to the US	accessdata.fda.gov
Hematoxylin	HYJ	1	Exporter to the US	accessdata.fda.gov
Iga, Antigen, Antiserum, Control	CZP	2	Exporter to the US	accessdata.fda.gov
Iga, Fitc, Antigen, Antiserum, Control	CZN	2	Exporter to the US	accessdata.fda.gov
Igg, Antigen, Antiserum, Control	DEW	2	Exporter to the US	accessdata.fda.gov
Igg, Fitc, Antigen, Antiserum, Control	DGK	2	Exporter to the US	accessdata.fda.gov
Igm (Mu Chain Specific), Antigen, Antiserum, Control	DAO	2	Exporter to the US	accessdata.fda.gov
Igm, Fitc, Antigen, Antiserum, Control	DFS	2	Exporter to the US	accessdata.fda.gov
Immunohistochemistry Assay, Antibody, Progesterone Receptor	MXZ	2	Exporter to the US	accessdata.fda.gov
Immunohistochemistry Reagents And Kits	NJT	1	Exporter to the US	accessdata.fda.gov
Kappa, Antigen, Antiserum, Control	DFH	2	Exporter to the US	accessdata.fda.gov
Kappa, Fitc, Antigen, Antiserum, Control	DEO	2	Exporter to the US	accessdata.fda.gov
Lambda, Antigen, Antiserum, Control	DEH	2	Exporter to the US	accessdata.fda.gov
Lambda, Fitc, Antigen, Antiserum, Control	DES	2	Exporter to the US	accessdata.fda.gov
Medical Device Data System	OUG	1	Exporter to the US	accessdata.fda.gov
Mounting Media	LEB	1	Exporter to the US	accessdata.fda.gov
Prealbumin, Antigen, Antiserum, Control	JZJ	1	Exporter to the US	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Exporter to the US	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Exporter to the US	accessdata.fda.gov
Research Use Only/Pathology	OTU	N	Exporter to the US	accessdata.fda.gov
Retinol-Binding Protein, Antigen, Antiserum, Control	CZS	1	Exporter to the US	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Exporter to the US	accessdata.fda.gov
Slide Stainer, Automated	KPA	1	Exporter to the US	accessdata.fda.gov
Slides, Microscope	KEW	1	Exporter to the US	accessdata.fda.gov
System, Test, Beta-2-Microglobulin Immunological	JZG	2	Exporter to the US	accessdata.fda.gov
System, Test, Her-2/Neu, Ihc	MVC	3	Exporter to the US	accessdata.fda.gov
System, Test, Her-2/Neu, Nucleic Acid Or Serum	MVD	2	Exporter to the US	accessdata.fda.gov
Test, Cystatin C	NDY	2	Exporter to the US	accessdata.fda.gov
Whole Human Serum, Antigen, Antiserum, Control	DGR	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 21, 2017	K170005	FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)	MXZ	Substantially Equivalent	Dako Denmark A/S	accessdata.fda.gov
September 3, 2004	K041627	CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR	NDY	Substantially Equivalent	Dako A/S	accessdata.fda.gov
January 22, 2004	K032692	DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368	JZG	Substantially Equivalent	Dako A/S	accessdata.fda.gov
June 21, 1999	K991454	MOUSE IGG1 NEGATIVE CONTROLS	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
June 21, 1999	K991402	DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 22, 1998	K980635	DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
June 24, 1997	K964974	MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
June 14, 1996	K960531	MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
May 17, 1996	K960887	MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
January 26, 1996	K945212	MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
April 20, 1995	K931192	DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY	DEH	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
November 21, 1994	K944253	MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
November 21, 1994	K943284	MONOCLONAL MOUSE ANTI-HUMAN B-CELL	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
November 10, 1994	K942797	MONOCLONAL MOUSE ANTI-HUMAN T-CELL	GKZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 19, 1983	K831907	RABBIT ANTISERUM TO HUMAN IGM	DFS	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 19, 1983	K831906	RABBIT ANTISERUM TO HUMAN C4	DBI	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 19, 1983	K831904	RABBIT ANTISERUM TO HUMAN KAPPA LIGHT	DEO	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 19, 1983	K831903	FLUORESCEIN CONJUGATED IMMUNOGLOBULIN	DES	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 18, 1983	K831909	RABBIT ANTISERUM TO HUMAN IGA	CZN	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 18, 1983	K831908	RABBIT ANTISERUM TO HUMAN IGG	DGK	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 18, 1983	K831905	RABBITT ANTISERUM TO HUMAN C3C	CZW	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
July 18, 1983	K831902	FLUORESCEIN CONJUGATED IMMUNOGLOBIN-	DDZ	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
September 29, 1981	K812662	IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA	DEH	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
September 29, 1981	K812661	IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA	DFH	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
September 23, 1981	K812495	IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA	DEW	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
September 23, 1981	K812489	IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG	DEW	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
September 23, 1981	K812488	IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA	CZP	Substantially Equivalent	Dako Corp.	accessdata.fda.gov
September 23, 1981	K812487	IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM	DAO	Substantially Equivalent	Dako Corp.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 3, 2005	P040005	DAKOCYTOMATION HER2 FISH PHARMDX KIT	MVD	14	April 12, 2017	accessdata.fda.gov
September 25, 1998	P980018	DAKO HERCEPTEST	MVC	27	September 21, 2026	accessdata.fda.gov

Compare with other makers

Updated December 21, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.