Manufacturer

Leicabiosystems

Australia, Germany, United Kingdom (ex Northern Ireland), United StatesLegal entities : Leica Biosystems Imaging, Inc., Leica Biosystems Melbourne Pty Ltd, Leica Biosystems Newcastle Ltd

Markets : Austria · Belgium · Denmark · Germany · Ireland · Netherlands · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 12 · PMA : 1 · class II, III · latest in 2026 · see on the FDA website

Public contracts won : Belgium 1 · Germany 1

EU representative : AR Experts B.V. (Netherlands)

Website support.de@LeicaBiosystems.com

20 categories, 324 models including 324 on the market, 4 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Primary antisera for immunohistology	W01030709	Alpha-Methylacyl-CoA Racemase EPMU1 7 mL PA021098/79 Anaplastic Lymphoma Kinase 5A4 7 mL PA083198/79 Bcl-2 bcl-2/100-D5 7 mL PA011798/79 Bcl-6 LN22 7 mL PA020498/79 c-erbB-2 Oncoprotein CB11 7mL PA098398/79 209 others c-erbB-2 Oncoprotein CB11 13.5mL PA057198/79 CA125 Ov185:1 7mL PA053998/79 Calretinin CAL6 7 mL PA034698/79 Carcinoembryonic Antigen (CD66e) COL-1 7 mL PA084898/79 CD10 56C6 30 mL PA013198/79 CD10 56C6 7 mL PA027098/79 CD117 EP10 7 mL PA000798/79 CD11c 5D11 7 mL PA055498/79 CD138 MI15 7 mL PA008898/79 CD15 MMA 7 mL PA047398/79 CD163 10D6 7 mL PA009098/79 CD19 BT51E 7 mL PA084398/79 CD1a MTB1 7 mL PA023598/79 CD20 L26 30 mL PA035998/79 CD20 L26 7 mL PA020098/79 CD23 1B12 7 mL PA016998/79 CD3 LN10 30 mL PA012298/79 CD3 LN10 7 mL PA055398/79 CD30 JCM182 7 mL PA079098/79 CD31 JC70A 7 mL PA041498/79 CD34 QBEnd/10 30 mL PA035498/79 CD34 QBEnd/10 7 mL PA021298/79 CD4 4B12 7 mL PA042798/79 CD45 X16/99 7 mL PA004298/79 CD45RO UCHL1 7 mL PA014698/79 CD5 4C7 7 mL PA016898/79 CD56 CD564 7 mL PA019198/79 CD68 514H12 7 mL PA027398/79 CD7 LP15 7 mL PA026698/79 CD8 4B11 7 mL PA018398/79 CDX2 EP25 7 mL PA037598/79 Chromogranin A 5H7 7 mL PA051598/79 Cyclin D1 EP12 7 mL PA004698/79 Cytokeratin 14 LL002 7 mL PA007498/79 Cytokeratin 19 b170 7 mL PA079998/79 Cytokeratin 20 Ks20.8 30 mL PA003798/79 Cytokeratin 20 Ks20.8 7 mL PA002298/79 Cytokeratin 5 XM26 7 mL PA046898/79 Cytokeratin 7 RN7 30 mL PA013898/79 Cytokeratin 7 RN7 7 mL PA094298/79 Cytokeratin AE1/AE3 7 mL PA009498/79 Desmin DE-R-11 7 mL PA003298/79 DOG-1 K9 7 mL PA021998/79 E-Cadherin 36B5 7 mL PA038798/79 Estrogen Receptor 6F11 30 mL PA000998/79 Estrogen Receptor 6F11 7 mL PA015198/79 Gastrin Polyclonal 7 mL PA068198/79 Glial Fibrillary Acidic Protein GA5 7 mL PA002698/79 Gross Cystic Disease Fluid Protein-15 23A3 7 mL PA070898/79 Herpesvirus (Type 8) 13B10 7 mL PA005098/79 Immunoglobulin D DRN1C 7 mL PA006198/79 Immunoglobulin G RWP49 7 mL PA090598/79 Immunoglobulin M 8H6 7 mL PA027898/79 Kappa Light Chain CH15 7 mL PA060698/79 Ki67 MM1 30 mL PA041098/79 Ki67 MM1 7 mL PA011898/79 Lambda Light Chain SHL53 7 mL PA057098/79 Mast Cell Tryptase 10D11 7 mL PA001998/79 Melan A A103 30 mL PA004498/79 Melan A A103 7 mL PA023398/79 Melanoma Marker HMB45 30 mL PA062598/79 Melanoma Marker HMB45 7 mL PA002798/79 Multiple Myeloma Oncogene 1 PA012998/79 Muramidase (Lysozyme) Polyclonal 7 mL PA039198/79 Myeloperoxidase 59A5 7 mL PA049198/79 Napsin A IP64 7 mL PA006498/79 NCL-b-DG98/79 NCL-d-SARC98/79 NCL-DRP298/79 NCL-DYS198/79 NCL-DYS298/79 NCL-DYS398/79 NCL-EMERIN98/79 NCL-g-SARC98/79 NCL-HAMLET98/79 NCL-HAMLET-298/79 NCL-L-5D398/79 NCL-L-a-SARC98/79 NCL-L-AE1/AE3-60198/79 NCL-L-AFP98/79 NCL-L-ALK98/79 NCL-L-AMACR98/79 NCL-L-AR-31898/79 NCL-L-B-CAT98/79 NCL-L-b-SARC98/79 NCL-L-bcl-298/79 NCL-L-Bcl-6-56498/79 NCL-L-CA12598/79 NCL-L-CAIX98/79 NCL-L-CALCITONIN98/79 NCL-L-CALRET-56698/79 NCL-L-CB1198/79 NCL-L-CD10-27098/79 NCL-L-CD117-03298/79 NCL-L-CD11c-56398/79 NCL-L-CD12398/79 NCL-L-CD13-30498/79 NCL-L-CD15-60598/79 NCL-L-CD1698/79 NCL-L-CD16398/79 NCL-L-CD19-16398/79 NCL-L-CD1a-23598/79 NCL-L-CD2-27198/79 NCL-L-CD20-L2698/79 NCL-L-CD21-2G998/79 NCL-L-CD23-1B1298/79 NCL-L-CD3-56598/79 NCL-L-CD30-59198/79 NCL-L-CD31-60798/79 NCL-L-CD3398/79 NCL-L-CD38-29098/79 NCL-L-CD4-36898/79 NCL-L-CD5-4C798/79 NCL-L-CD56-50498/79 NCL-L-CD6898/79 NCL-L-CD7-58098/79 NCL-L-CD71-30998/79 NCL-L-CD8-4B1198/79 NCL-L-CD99-18798/79 NCL-L-CEA-60998/79 NCL-L-CHROM-43098/79 NCL-L-CK1798/79 NCL-L-CK2098/79 NCL-L-CK598/79 NCL-L-CK7-56098/79 NCL-L-CK7-OVTL98/79 NCL-L-CYCLIN D1-GM98/79 NCL-L-DES-DERII98/79 NCL-L-DOG-198/79 NCL-L-E-Cad98/79 NCL-L-EGFR98/79 NCL-L-EMA98/79 NCL-L-END98/79 NCL-L-ER-6F1198/79 NCL-L-ER-6F11/298/79 NCL-L-EZH298/79 NCL-L-FRalpha98/79 NCL-L-GCDFP1598/79 NCL-L-GEMININ98/79 NCL-L-GFAP-GA598/79 NCL-L-GRAN-B98/79 NCL-L-HHV8-LNA98/79 NCL-L-HMB4598/79 NCL-L-Hpylori98/79 NCL-L-IgA98/79 NCL-L-IgD98/79 NCL-L-IgG98/79 NCL-L-IgM98/79 NCL-L-InhibinA98/79 NCL-L-KAP-58198/79 NCL-L-Ki67-MM198/79 NCL-L-LAM-57898/79 NCL-L-LANGERIN98/79 NCL-L-LCA98/79 NCL-L-LL00298/79 NCL-L-MelanA98/79 NCL-L-MESO98/79 NCL-L-MLH198/79 NCL-L-MSA-59498/79 NCL-L-MSH2-61298/79 NCL-L-MSH698/79 NCL-L-MUM198/79 NCL-L-Myf-498/79 NCL-L-NAPSINA NCL-L-NAPSIN A98/79 NCL-L-NF200-N5298/79 NCL-L-OCT3/498/79 NCL-L-p53-DO798/79 NCL-L-p5798/79 NCL-L-p6398/79 NCL-L-PAX-598/79 NCL-L-PGP9.598/79 NCL-L-PGR-31298/79 NCL-L-PGR-312/298/79 NCL-L-PLAP-8A998/79 NCL-L-PMS298/79 NCL-L-PTH-48898/79 NCL-L-S100-16798/79 NCL-L-SMA98/79 NCL-L-SYNAP-29998/79 NCL-L-TDT-33998/79 NCL-L-TPO98/79 NCL-L-TTF-198/79 NCL-L-TYROS98/79 NCL-L-VIM-V998/79 NCL-L-vWF98/79 NCL-L-WT1-56298/79 NCL-MEROSIN98/79 NCL-SPEC198/79 Negative (Rabbit) 7mL PA0777 Negative (Rabbit) 7mL PA0996 Neurofilament 200kD N52.1.7 7 mL PA037198/79 Novocastra Enzyme Proteinase K (IHC) RE7160-K Novocastra Polymer Detection System (250 tests) RE7140-K3 refs Oct-3/4 N1NK 7 mL PA019398/79 p16 6H12 7 mL PA001698/79 p53 DO-7 7 mL PA005798/79 p63 7JUL 7 mL PA010398/79 Pax-5 1EW 7 mL PA055298/79 Placental Alkaline Phosphatase 8A9 7 mL PA016198/79 Progesterone Receptor 16 30 mL PA043698/79 Progesterone Receptor 16 7 mL PA031298/79 Programmed Death Ligand 1 73-10 7 mL PA083298/79 S-100 EP32 7 mL PA003198/79 Smooth Muscle Actin αsm-1 7 mL PA094398/79 Synaptophysin 27G12 7 mL PA0299 Thyroid Transcription Factor-1 SPT24 7 mL PA036498/79 Vimentin V9 7 mL PA064098/79 von Willebrand Factor 36B11 7 mL PA005598/79 Wilms' Tumor WT49 7 mL PA056298/79	A, B, C IVDR, 98/79	EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other	W0103010199	Anti-Biotin Antibody AR0584 Anti-Fluorescein Antibody AR02222 refs BOND DAB Enhancer AR9432 BOND Dewax Solution AR9222 BOND Enzyme Pretreatment Kit AR9551 11 others BOND Epitope Retrieval Solution 1 AR9961 BOND Epitope Retrieval Solution 2 AR9640 BOND Hybridization Solution AR9037 BOND Primary Antibody Diluent AR9352 BOND Wash Solution 10X Concentrate AR9590 BOND-PRIME Dewax Solution AR0084 BOND-PRIME Epitope Retrieval Solution 1 AR0086 BOND-PRIME Epitope Retrieval Solution 2 AR0087 BOND-PRIME Hematoxylin AR0096 BOND-PRIME Wash Solution Concentrate AR0085 Stringency Wash Solution AR0633	A IVDR	EUDAMED record Report an error
DNA in situ hybridisation reagents	W01030703	DNA Negative Control 6.25 mL PB073198/79 DNA Positive Control Probe 6.25 mL PB068298/79 EBER Probe 5.5 mL PB058998/79 FISH Digestion Kit KBI-60006 FISH Reagent Kit KBI-60005 8 others HPV Probe (subtypes 16, 18, 31, 33, 51) 6.25 mL PB082998/79 HPV Probe (subtypes 6, 11) 6.25 mL PB078098/79 Kappa Probe 5.5 mL PB064598/79 Lambda Probe 5.5 mL PB066998/79 RNA Negative Control Probe PB080998/79 RNA Positive Control probe 5.5 mL PB078598/79 Tissue Digestion Kit I KBI-60007 Tissue Digestion Kit II KBI-60004	A IVDR, 98/79	EUDAMED record Report an error
Histology / cytology reagents - other	W01030799	Epitope Retrieval Solution (x10 Concentrate) pH6 RE7113 Epitope Retrieval Solution (x10 Concentrate) pH8 RE7116 Epitope Retrieval Solution (x10 Concentrate) pH9 RE7119 MAX DAB (Polymer) 1250 tests) RE7230-K2 refs Novocastra Hematoxylin RE7107 6 others Novocastra IHC Diluent RE7133 Novocastra Peroxidase Block RE7101 Novocastra Peroxidase Detection System (250 tests) RE7110-K Novocastra Protein Block RE7102 Novocastra Streptavidin-HRP RE7104 Novolink Max Polymer (1250 tests) RE7200-K2 refs	A IVDR	EUDAMED record Report an error
IVD general use consumable devices - other	W0599	10% Neutral Buffered Formalin3 refs Acrytol3 refs ActivFlo Biopsy II, Taped, Orange3 refs APEX SUPERIOR ADHESIVE SLIDE - BLUE3 refs Biopsy Bags3 refs 5 others Blue Ribbon3 refs Frostbite FSC22 Blue Frozen Section Compound3 refs HistoCore Spectra CV Cover Glass3 refs LP Biopsy I Cassettes, Blue3 refs	A IVDR	EUDAMED record Report an error
Immunohistology kits	W01030711	BOND FISH Kit DS9636 BOND Oracle HER2 IHC System TA914598/79 BOND Polymer Refine Detection DS9800 BOND Polymer Refine Red Detection DS9390 BOND RNAScope Brown Detection DS9815 4 others BOND-PRIME Polymer AP Detection System DS9304 BOND-PRIME Polymer DAB Detection System DS9284 ChromoPlex 1 Dual Detection DS94772 refs ChromoPlex 1 Dual Detection for BOND-PRIME DS9397	A IVDR, 98/79	EUDAMED record Report an error
Digital laboratory microscopes	W0202050304	23GT450DXIVD Aperio CS5 DX 23CS5DXIVD Aperio GT 180 DX 23GT180DXIVD Aperio GT 450 DX (refurbished) Aperio GT 450 SAM DX Software 2 others Aperio SAM DX 23APERIOSAMSWDX1 CytoVision DX 23GSL10XBFF230DX3 refs	A IVDR	EUDAMED record Report an error
Histo / cyto stains	W0103010301	0.5% Acid Alcohol3 refs Alcoholic Eosin Y 5153 refs EA-503 refs Harris Hematoxylin3 refs HistoCore SPECTRA CV X1 Mounting Media3 refs 2 others Scott’s Tap Water Substitute Working Solution3 refs ST Infinity 2.0 H&E Staining System2 refs	A IVDR	EUDAMED record Report an error
Tissue processors	W0202059010	ASP6025 S3 refs Basket Spaced3 refs HistoCore PEARL HistoCore PEGASUS HistoCore PEGASUS Plus 2 others Leica ASP300 S2 refs Leica TP10203 refs	A IVDR	EUDAMED record Report an error
Automated slide stainers	W0202059002	BOND Controller (7.0)3 refs HistoCore CHROMAX ST HistoCore SPECTRA ST Leica Autostainer XL (ST5010)2 refs Leica ST4020	A IVDR	EUDAMED record Report an error
Cryostat microtomes	W0202059003	Leica CM15203 refs Leica CM18602 refs Leica CM1860 UV2 refs Leica CM19503 refs Leica CM3050 S3 refs	A IVDR	EUDAMED record Report an error
Microtomes	W0202059005	HistoCore AUTOCUT3 refs HistoCore BIOCUT3 refs HistoCore MULTICUT3 refs Leica RM2125 RTS3 refs Leica SM2010 R3 refs	A IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - consumables	W02079085	Bond Open Container 30 mL OP309700 Bond Open Container 7 mL OP79193 BOND Titration Container 6 mL OPT9049 BOND Titration Container Inserts 50 Pack OPT9719	A IVDR	EUDAMED record Report an error
Automated coverslippers	W0202059008	HistoCore CHROMAX CV2 refs HistoCore SPECTRA CV Leica CV50303 refs	A IVDR	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	BOND Aspirating Probe Cleaning System CS9100 BOND-PRIME Cleaning Kit CS9300	A IVDR	EUDAMED record Report an error
Laboratory instruments for microscopic investigations - software accessories	W0202050382	23WVROWIVD Aperio HALO AP 23HALOAP	A IVDR	EUDAMED record Report an error
IVD instruments - other	W0299	ThermoBrite Slide Denaturation/ Hybridization System, 120V3 refs	A IVDR	EUDAMED record Report an error
Laboratory instruments for microscopic investigations - hardware accessories	W0202050380	ThermoBrite Elite Instrument 3800-007000-001	A IVDR	EUDAMED record Report an error
Laboratory instruments for microscopic investigations - IVD medical device software	W0202050392	Aperio iQC DX 23iQCDXROW	A IVDR	EUDAMED record Report an error
Thermostatic water baths	W02079001	HistoCore Water Bath M	A IVDR	EUDAMED record Report an error

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