Medical device licence · 77188 · Class 2
BOND
Yes: licensed in Canada
Licence status Issued (active); first licensed May 26, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77188
- Licence holder
- Leica Biosystems Newcastle Ltd.Newcastle Upon Tyne, TW, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 26, 2008
- Devices covered
- 167
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BOND ANTI-FLUORESCEIN ANTIBODY
- BOND CHROMOPLEX 1 DUAL DETECTION
- BOND DAB ENHANCER
- BOND DEWAX SOLUTION
- BOND DILUENT
- BOND ENZYME PRE-TREATMENT KIT
- BOND EPITOPE RETRIEVAL SOLUTION
- BOND FISH KIT
- BOND HYBRIDIZATION SOLUTION
- BOND ORACLE HER2 IHC SYSTEM
- BOND POLYMER REFINE DETECTION
- BOND POLYMER REFINE RED DETECTION
- BOND READY TO USE ANTI-BIOTIN ANTIBODY
- BOND READY TO USE ANTIBODY C-ERBB-2 ONCOPROTEIN
- BOND READY TO USE ISH DNA NEGATIVE CONTROL PROBE
- BOND READY TO USE ISH DNA POSITIVE CONTROL PROBE
- BOND READY TO USE ISH EBER PROBE
- BOND READY TO USE ISH KAPPA PROBE
- BOND READY TO USE ISH LAMBDA PROBE
- BOND READY TO USE ISH RNA CONTROL PROBE
- BOND READY TO USE PRIMARY ANTIBODY CD7(LP15)
- BOND READY TO USE PRIMARY ANTIBODY MLH1(MISMATCH REPAIR PROTEIN) (ES05)
- BOND READY TO USE PRIMARY ANTIBODY VIMENTIN(V9)
- BOND READY TO USE PRIMARY ANTIBODY ALPHA-FETOPROTEIN(C3)
- BOND READY TO USE PRIMARY ANTIBODY ANAPLASTIC LYMPHOMA KINASE (5A4)
- BOND READY TO USE PRIMARY ANTIBODY BCL-2(BCL-2/100/D5)
- BOND READY TO USE PRIMARY ANTIBODY BCL-6(LN22)
- BOND READY TO USE PRIMARY ANTIBODY BETA-CATENIN(17C2)
- BOND READY TO USE PRIMARY ANTIBODY BOB-1(TG14)
- BOND READY TO USE PRIMARY ANTIBODY C-ERB-B2 ONCOPROTEIN
- BOND READY TO USE PRIMARY ANTIBODY CA125(OV185:1)
- BOND READY TO USE PRIMARY ANTIBODY CA19-9 (SIALYL LEWISA)(C241:5:1:4)
- BOND READY TO USE PRIMARY ANTIBODY CALCITONIN(POLYCLONAL)
- BOND READY TO USE PRIMARY ANTIBODY CALPONIN B(26A11)
- BOND READY TO USE PRIMARY ANTIBODY CALRETININ(CAL6)
- BOND READY TO USE PRIMARY ANTIBODY CARCINOEMBRYONIC ANTIGEN(11-7)
- BOND READY TO USE PRIMARY ANTIBODY CD10(56C6)
- BOND READY TO USE PRIMARY ANTIBODY CD103(EP206)
- BOND READY TO USE PRIMARY ANTIBODY CD11C(5D11)
- BOND READY TO USE PRIMARY ANTIBODY CD13 (38C12)
- BOND READY TO USE PRIMARY ANTIBODY CD138 (SYNDECAN-1)(MI15)
- BOND READY TO USE PRIMARY ANTIBODY CD15 (MMA)
- BOND READY TO USE PRIMARY ANTIBODY CD15(CARB-1)
- BOND READY TO USE PRIMARY ANTIBODY CD163 (10D6)
- BOND READY TO USE PRIMARY ANTIBODY CD19(BT51B)
- BOND READY TO USE PRIMARY ANTIBODY CD1A(MTB1)
- BOND READY TO USE PRIMARY ANTIBODY CD2(11F11)
- BOND READY TO USE PRIMARY ANTIBODY CD20(L26)
- BOND READY TO USE PRIMARY ANTIBODY CD21(2G9)
- BOND READY TO USE PRIMARY ANTIBODY CD22(FPC1)
- BOND READY TO USE PRIMARY ANTIBODY CD23(1B12)
- BOND READY TO USE PRIMARY ANTIBODY CD25(4C9)
- BOND READY TO USE PRIMARY ANTIBODY CD3(LN10)
- BOND READY TO USE PRIMARY ANTIBODY CD30(JCM182)
- BOND READY TO USE PRIMARY ANTIBODY CD31(1A10)
- BOND READY TO USE PRIMARY ANTIBODY CD33(PWS44)
- BOND READY TO USE PRIMARY ANTIBODY CD34(QBEND/10)
- BOND READY TO USE PRIMARY ANTIBODY CD4(4B12)
- BOND READY TO USE PRIMARY ANTIBODY CD43(MT1)
- BOND READY TO USE PRIMARY ANTIBODY CD45(X16/99)
- BOND READY TO USE PRIMARY ANTIBODY CD45RO(UCHL1)
- BOND READY TO USE PRIMARY ANTIBODY CD5(4C7)
- BOND READY TO USE PRIMARY ANTIBODY CD56(CD564)
- BOND READY TO USE PRIMARY ANTIBODY CD57(NK-1)
- BOND READY TO USE PRIMARY ANTIBODY CD61(212)
- BOND READY TO USE PRIMARY ANTIBODY CD68(514H12)
- BOND READY TO USE PRIMARY ANTIBODY CD79A (JCB117)
- BOND READY TO USE PRIMARY ANTIBODY CD79A(11E3)
- BOND READY TO USE PRIMARY ANTIBODY CD8(4B11)
- BOND READY TO USE PRIMARY ANTIBODY CD99(HO-36.1.1)
- BOND READY TO USE PRIMARY ANTIBODY CDX2(EP25)
- BOND READY TO USE PRIMARY ANTIBODY CHROMOGRANIN A(5H7)
- BOND READY TO USE PRIMARY ANTIBODY CYCLIN D1 (EP12)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN (AE1/AE3)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN 14 (LL002)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN 17 (E3)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN 19(B170)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN 20(KS20.8)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN 5(XM26)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN 7(RN7)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN 8(TS1)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN 8/18( 5D3)
- BOND READY TO USE PRIMARY ANTIBODY CYTOKERATIN HMW(34BE12)
- BOND READY TO USE PRIMARY ANTIBODY DESMIN(DE-R-11)
- BOND READY TO USE PRIMARY ANTIBODY DOG-1(K9)
- BOND READY TO USE PRIMARY ANTIBODY E-CADHERIN(36B5)
- BOND READY TO USE PRIMARY ANTIBODY EPITHELIAL MEMBRANE ANTIGEN(GP1.4)
- BOND READY TO USE PRIMARY ANTIBODY ESTROGEN RECEPTOR(6F11)
- BOND READY TO USE PRIMARY ANTIBODY FACTOR XIIIA(E980.1)
- BOND READY TO USE PRIMARY ANTIBODY FASCIN(IM20)
- BOND READY TO USE PRIMARY ANTIBODY GALECTIN-3(9C4)
- BOND READY TO USE PRIMARY ANTIBODY GASTRIN (POLYCLONAL)
- BOND READY TO USE PRIMARY ANTIBODY GLIAL FIBRILLIARY ACIDIC PROTEIN(GA5)
- BOND READY TO USE PRIMARY ANTIBODY GLUCAGON (POLYCLONAL)
- BOND READY TO USE PRIMARY ANTIBODY GRANZYME B(11F1)
- BOND READY TO USE PRIMARY ANTIBODY GROSS CYSTIC DISEASE FLUID PROTEIN-15(23A3)
- BOND READY TO USE PRIMARY ANTIBODY HUMAN CHORIONIC GONADOTROPHIN (POLYCLONAL)
- BOND READY TO USE PRIMARY ANTIBODY HUMAN FOLLICLE STIMULATING HORMONE(INN-HFSH-60)
- BOND READY TO USE PRIMARY ANTIBODY HUMAN GROWTH HORMONE(POLYCLONAL)
- BOND READY TO USE PRIMARY ANTIBODY IMMUNOGLOBULIN G (RWP49)
- BOND READY TO USE PRIMARY ANTIBODY IMMUNOGLOBULIN M(8H6)
- BOND READY TO USE PRIMARY ANTIBODY INHIBIN (ALPHA)(R1)
- BOND READY TO USE PRIMARY ANTIBODY INSULIN(2D11-H5)
- BOND READY TO USE PRIMARY ANTIBODY K167 (K2)
- BOND READY TO USE PRIMARY ANTIBODY KAPPA LIGHT CHAIN (CH15)
- BOND READY TO USE PRIMARY ANTIBODY KI67 MM1
- BOND READY TO USE PRIMARY ANTIBODY LAMBDA LIGHT CHAIN (SHL53)
- BOND READY TO USE PRIMARY ANTIBODY LUTEINIZING HORMONE(C93)
- BOND READY TO USE PRIMARY ANTIBODY MACROPHAGE MARKER(LN-5)
- BOND READY TO USE PRIMARY ANTIBODY MAMMAGLOBIN (EP249)
- BOND READY TO USE PRIMARY ANTIBODY MAST CELL TRYPTASE(10D11)
- BOND READY TO USE PRIMARY ANTIBODY MELAN A(A103)
- BOND READY TO USE PRIMARY ANTIBODY MELANOMA MARKER (HMB45)
- BOND READY TO USE PRIMARY ANTIBODY MESOTHELIN(5B2)
- BOND READY TO USE PRIMARY ANTIBODY MSH2 (MISMATCH REPAIR PROTEIN)(25D12)
- BOND READY TO USE PRIMARY ANTIBODY MSH6 (MISMATCH REPAIR PROTEIN) (PU29)
- BOND READY TO USE PRIMARY ANTIBODY MUC-2 GYCOPROTEIN (CCP58)
- BOND READY TO USE PRIMARY ANTIBODY MULTI-CYTOKERATIN(AE1/AE3)
- BOND READY TO USE PRIMARY ANTIBODY MULTIPLE MYELOMA ONCOGENE 1 (MUM1)(EAU32)
- BOND READY TO USE PRIMARY ANTIBODY MURAMIDASE (LYSOZYME)(POLYCLONAL)
- BOND READY TO USE PRIMARY ANTIBODY MUSCLE SPECIFIC ACTIN (HHF35)
- BOND READY TO USE PRIMARY ANTIBODY MYELOPEROXIDASE(59A5)
- BOND READY TO USE PRIMARY ANTIBODY MYF-4(LO26)
- BOND READY TO USE PRIMARY ANTIBODY MYOGLOBULIN(MYO18)
- BOND READY TO USE PRIMARY ANTIBODY MYOSIN HEAVY CHAIN (SMOOTH MUSCLE)(S131)
- BOND READY TO USE PRIMARY ANTIBODY NEGATIVE (MOUSE)
- BOND READY TO USE PRIMARY ANTIBODY NEGATIVE (RABBIT)
- BOND READY TO USE PRIMARY ANTIBODY NEUROFILAMENT 200KD(N52.1.7)
- BOND READY TO USE PRIMARY ANTIBODY NEURON SPECIFIC ENOLASE(22C9)
- BOND READY TO USE PRIMARY ANTIBODY OCT-2(OCT-207)
- BOND READY TO USE PRIMARY ANTIBODY OCT-3/4 (N1NK)
- BOND READY TO USE PRIMARY ANTIBODY P120 CATENIN(EP66)
- BOND READY TO USE PRIMARY ANTIBODY P53(DO-7)
- BOND READY TO USE PRIMARY ANTIBODY P63(7JUL)
- BOND READY TO USE PRIMARY ANTIBODY P63(DO-7)
- BOND READY TO USE PRIMARY ANTIBODY PAX-5(1EW)
- BOND READY TO USE PRIMARY ANTIBODY PLACENTAL ALKALINE PHOSPHATASE
- BOND READY TO USE PRIMARY ANTIBODY PROGESTERONE RECEPTOR(16)
- BOND READY TO USE PRIMARY ANTIBODY PROSTATE SPECIFIC ANTIGEN(35H9)
- BOND READY TO USE PRIMARY ANTIBODY PROSTATIC ACID PHOSPHATASE(PASE/4LJ)
- BOND READY TO USE PRIMARY ANTIBODY PROTEIN GENE PRODUCT 9.5(10A1)
- BOND READY TO USE PRIMARY ANTIBODY S-100(POLYCLONAL)
- BOND READY TO USE PRIMARY ANTIBODY SEROTONIN(POLYCLONAL)
- BOND READY TO USE PRIMARY ANTIBODY SMOOTH MUSCLE ACTIN(ASM-1)
- BOND READY TO USE PRIMARY ANTIBODY SOMATOSTATIN(T311)
- BOND READY TO USE PRIMARY ANTIBODY SYNAPTOPHYSIN(27G12)
- BOND READY TO USE PRIMARY ANTIBODY TARTRATE-RESISTANCE ACID PHOSPHATASE (26E5)
- BOND READY TO USE PRIMARY ANTIBODY TERMINAL DEOXYNUCLEOTIDYL TRANSFERASE(SEN28)
- BOND READY TO USE PRIMARY ANTIBODY THYROGLOBULIN(1D4)
- BOND READY TO USE PRIMARY ANTIBODY THYROID STIMULATING HORMONE(OB2/6)
- BOND READY TO USE PRIMARY ANTIBODY THYROID TRANSCRIPTION FACTOR-1(SPT24)
- BOND READY TO USE PRIMARY ANTIBODY TYROSINASE(T311)
- BOND READY TO USE PRIMARY ANTIBODY VILLIN(CWWB1)
- BOND READY TO USE PRIMARY ANTIBODY VON WILLEBRAND FACTOR(36B11)
- BOND READY TO USE PRIMARY ANTIBODY WILM'S TUMOUR(WT49)
- BOND READY TO USE PRIMARY ANTOBODY CARCINOEMBRYONIC ANTIGEN (CD66E)(COL-1)
- BOND READY TO USE STRINGENCY WASH SOLUTION
- BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMUI)
- BOND READY-TO-USE PRIMARY ANTIBODY CD117 (EP10)
- BOND READY-TO-USE PRIMARY ANTIBODY CD31 (JC70A)
- BOND READY-TO-USE PRIMARY ANTIBODY HUMAN HERPESVIRUS (TYPE 8)
- BOND READY-TO-USE PRIMARY ANTIBODY IMMUNOGLOBULIN D (DRN1C)
- BOND READY-TO-USE PRIMARY ANTIBODY MUC-1 GLYCOPROTEIN (MA695)
- BOND READY-TO-USE PRIMARY ANTIBODY MUC-5AC GLYCOPROTEIN (CLH2)
- BOND READY-TO-USE PRIMARY ANTIBODY MUC-6 GLYCOPROTEIN (CLH5)
- BOND READY-TO-USE PRIMARY ANTIBODY NAPSIN A (IP64)
- BOND WASH SOLUTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.