Manufacturer

Biocyc

GermanyLegal entities : biocyc Biotechnologie GmbH & Co. KG

Markets : Germany

Approvals : EU – class A, C

3 categories, 203 models including 203 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Primary antisera for immunohistology	W01030709	Albumin FITC4 refs98/79 ALK (QR017)3 refs AMACR (QR108)3 refs Androgen receptor (QR135)3 refs Arginase-1 (QR083)7 refs98/79 151 others BAP1 (QR119)3 refs Bcl2 (QR062)7 refs98/79 Bcl6 (QR047)7 refs98/79 Beta-Catenin (QR095)7 refs98/79 BOB.1 (QR072)7 refs98/79 c-Myc (QR061)3 refs C1q FITC4 refs98/79 C3c FITC4 refs98/79 C4c FITC4 refs98/79 C4d (QR053)7 refs98/79 Cadherin 17 (QR098)7 refs98/79 Caldesmon (QR063)7 refs98/79 Calponin 1 (QR139)3 refs Calretinin (QR059)7 refs98/79 Carbonic anhydrase 9 (QR114)3 refs CD10 (QR021)3 refs CD103 (QR081)7 refs98/79 CD117 (QR012)3 refs CD138 (QR102)7 refs98/79 CD15 (MMA)7 refs98/79 CD171/L1CAM (QR039)7 refs98/79 CD1a (QR123)3 refs CD20 (QR094)7 refs98/79 CD21 (QR076)7 refs98/79 CD23 (QR036)7 refs98/79 CD30 (QR109)7 refs98/79 CD31 (QR034)7 refs98/79 CD34 (QR093)7 refs98/79 CD3e (QR004)3 refs CD4 (QR032)7 refs98/79 CD45/LCA (QR106)7 refs98/79 CD5 (QR111)7 refs98/79 CD56 (QR044)7 refs98/79 CD68 (QR105)3 refs CD71 (QR073)7 refs98/79 CD79a (QR033)7 refs98/79 CD8 (QR068)7 refs98/79 CD99 (QR067)7 refs98/79 CDK4 (QR115)3 refs CDX2 (QR045)7 refs98/79 CEA (QR117)3 refs Chromogranin A (QR096)7 refs98/79 Claudin 4 (QR137)3 refs Cyclin D1 (QR022)7 refs98/79 Cytokeratin 14 (QR057)7 refs98/79 Cytokeratin 18 (QR147)3 refs Cytokeratin 19 (QR125)3 refs Cytokeratin 20 (Ks20.8)7 refs98/79 Cytokeratin 5 (QR027)7 refs98/79 Cytokeratin 5/14 (QR027 & QR057)7 refs98/79 Cytokeratin 5/6 (QR027 & QR028)7 refs98/79 Cytokeratin 6 (QR028)7 refs98/79 Cytokeratin 7 (QR049)7 refs98/79 Cytokeratin 8 (QR112)7 refs98/79 Cytokeratin HMW (34betaE12)7 refs98/79 Cytokeratin pan (MNF116)7 refs98/79 Cytokeratin pan (QR124)3 refs Desmin (QR026)7 refs98/79 DOG1 (QR070)7 refs98/79 E-Cadherin (QR035)7 refs98/79 EGFR (QR078)7 refs98/79 EMA (QR118)3 refs ERG (QR040)7 refs98/79 Estrogen Receptor (QR013)3 refs Factor XIIIa (QR086)7 refs98/79 Fibrinogen FITC4 refs98/79 GATA3 (QR018)3 refs GFAP (QR066)7 refs98/79 GLUT1 (QR082)7 refs98/79 Glutamine synthetase (QR090)7 refs98/79 Glypican 3 (QR103)7 refs98/79 Granzyme B (QR130)3 refs Helicobacter pylori (QR091)7 refs98/79 Hep Par-1 (QR122)3 refs Her2/Neu (QR003)7 refs98/79 Histone H3.3 G34W (QR133)3 refs HSP70 (QR087)7 refs98/79 IDH1 R132H (QM002)7 refs98/79 IgA (QR050)7 refs98/79 IgA FITC4 refs98/79 IgG FITC4 refs98/79 IgG4 (QR092)7 refs98/79 IgM FITC4 refs98/79 Inhibin alpha (QR088)7 refs98/79 INSM1 (QR128)3 refs IRTA1 (QM005)3 refs98/79 Kappa FITC4 refs98/79 Kappa light chain (QR051)7 refs98/79 Ki-67 (QR015) Ki67 (QR015)3 refs Lambda FITC4 refs98/79 Lambda light chain (QR052)7 refs98/79 Langerin (QR065)7 refs98/79 Mammaglobin (QR080)7 refs98/79 MDM2 (SMP14)6 refs98/79 Melan A (A103)7 refs98/79 Melan A (QR138)3 refs Melanoma (HMB-45)7 refs98/79 MLH1 (QM003)3 refs MPO (QR101)7 refs98/79 MSH2 (QR010)3 refs MSH6 (QR011)3 refs MTAP (QR131)3 refs MUM1 (QR075)7 refs98/79 MyoD1 (QR069)7 refs98/79 Myogenin (QR089)7 refs98/79 Myosin heavy chain 11 (QR064)7 refs98/79 Napsin A (QR058)6 refs98/79 Napsin A (QR058) C-N002-02598/79 NKX2.2 (QR077)7 refs98/79 NKX3.1 (QR055)3 refs NSE (QR104)6 refs98/79 NSE (QR105) NSE (QR104)98/79 NUT (QR043)7 refs98/79 Olig2 (QR071)7 refs98/79 p16 (QR019)3 refs p21 (QR085)7 refs98/79 p40 (QR020)6 refs98/79 p40 (QR152)3 refs p53 (QR025)7 refs98/79 p63 (QR007)3 refs pan-TRK (QR008)7 refs98/79 PAX2 (QR060)7 refs98/79 PAX5 (QR056)7 refs98/79 PAX8 (QR016)3 refs PD-1 (QR002)7 refs98/79 PD-L1 (QR001)7 refs98/79 PIN-Cocktail AMACR/p63 (QR108 & QM006)3 refs PLAP (QR084)7 refs98/79 PMS2 (QR009)3 refs Podoplanin (QR048)7 refs98/79 PRAME (QR005)3 refs Progesterone Receptor (QR014) Progesteron Receptor (QR014)3 refs PSA (QR038)3 refs PSMA (QR079)7 refs98/79 PTEN (QR042)7 refs98/79 S100B (QR031)7 refs98/79 SALL4 (QR024)7 refs98/79 SATB2 (QR023)3 refs SMA (QR110)3 refs SMAD4 (QR029)7 refs98/79 SMARCA4 (QR132)3 refs SOX10 (QR006)3 refs SOX11 (QR074)7 refs98/79 STAT6 (QR041)3 refs Synaptophysin (QR054)7 refs98/79 TdT (QR037)7 refs98/79 TRPS1 (QR099)3 refs TTF1 (QR046)7 refs98/79 Tyrosinase (T311)7 refs98/79 Vimentin (QR097)7 refs98/79 WT1 (QR030)7 refs98/79	C IVDR, 98/79	EUDAMED record Report an error
Histology / cytology reagents - other	W01030799	Q Block FITC Protein Q Block Peroxidase Quench Q Block Protein BL-002-0050 Q Buffer Citrate EDTA, pH 7.5 (RTU)2 refs Q Buffer EDTA, pH 8.0 (50x) 22 others Q Buffer PBS, pH 7.6 (25x)3 refs Q Buffer Phosphate by Soerensen, pH 7.4 (RTU)3 refs Q Buffer Phosphate, pH 7.4 (50x)2 refs Q Buffer TBS with 0.04 % Tween20, pH 7.6 (50x)2 refs Q Buffer TBS, pH 7.6 (50x)2 refs Q Buffer TRIS HCl, pH 7.6 (RTU)2 refs Q Buffer TRIS Washbuffer for Automated Stainer, pH 7.4 (40x)2 refs Q Dewax Solution3 refs Q Diluent for IHC2 refs Q Diluent for IHC w/o Green Q Fix 10 % Buffered Neutral Formalin3 refs Q Fix Carnoy Q Fix Karnovsky3 refs Q Fix Michel´s 1 (Fixative/Transport) Q Fix Michel´s 2 (Fixative) Q Mount Aqua3 refs Q Mount Fluor2 refs Q Mount Fluor Anti Fading Q Mount Permanent (w/o Xylene, Toluol)4 refs Q Retrieval Pronase Q Retrieval High pH 9.0 (50x)2 refs Q Retrieval Low pH 6.0 (50x)	A IVDR	EUDAMED record Report an error
Immunohistology kits	W01030711	p40 (QR020)98/79 PolyQ Stain 1 step detection system goat anti-mouse AP3 refs PolyQ Stain 1 step detection system goat anti-mouse HRP3 refs PolyQ Stain 1 step detection system goat anti-mouse HRP, Peroxidase quench, DAB kit3 refs PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP3 refs 15 others PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP, Permanent Red kit3 refs PolyQ Stain 1 step detection system goat anti-mouse/rabbit HRP3 refs PolyQ Stain 1 step detection system goat anti-mouse/rabbit HRP, Peroxidase quench, DAB kit3 refs PolyQ Stain 1 step detection system goat anti-rabbit AP3 refs PolyQ Stain 1 step detection system goat anti-rabbit HRP3 refs PolyQ Stain 1 step detection system goat anti-rabbit HRP, Peroxidase quench, DAB kit3 refs PolyQ Stain 1 step double stain goat anti-mouse HRP, goat anti-rabbit AP3 refs PolyQ Stain 1 step double stain goat anti-rabbit HRP, goat anti-mouse AP3 refs PolyQ Stain 2 step detection system goat anti-mouse/rabbit AP3 refs PolyQ Stain 2 step detection system goat anti-mouse/rabbit AP, Permanent Red kit3 refs PolyQ Stain 2 step detection system goat anti-mouse/rabbit HRP3 refs PolyQ Stain 2 step detection system goat anti-mouse/rabbit HRP, Peroxidase quench, DAB kit3 refs PolyQ Stain DAB Substrate Buffer3 refs PolyQ Stain DAB, 2 components3 refs PolyQ Stain Permanent Red, 2 components3 refs	A IVDR, 98/79	EUDAMED record Report an error

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