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Cell Marque - Instructions for Use
Cell Marque - Safety Data Sheet
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"NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Storage Conditions (Product)", "Value": "Store at 2-8°C. Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Applications", "Value": "Anti-PSA (ER-PR8) may be used as the primary antibody for immunohistochmical staining of formalin-fixed, paraffin-embedded tissue sections.", "Language": "en", "Country": "XG", "Code": "Applications" }, { "Name": "Content", "Value": "One dispenser of the stated primary antibody (760-4930) contains sufficient prediluted reagent for 50 tests. The antibody is diluted in Tris Buffer, pH 7.3-7.7, with 1% BSA and <0.1% Sodium Azide.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Product Purpose", "Value": "Anti-PSA (ER-PR8) may be used as the primary antibody for immunohistochmical staining of formalin-fixed, paraffin-embedded tissue sections.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }
PSA (ER-PR8) Mouse Monoclonal Antibody
RUO
RUO
For Research Use Only. Not for use in diagnostic procedures.
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IVD
For in vitro diagnostic use.
Granzyme B Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
GCDFP-15 (EP1582Y) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
Gastrin Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
Galectin-3 (9C4) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
GATA3 (L50-823) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
Glucagon Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
Glutamine Synthetase (GS-6) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
Glycophorin A (GA-R2) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
GLUT1 Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
Glypican-3 (1G12) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
GH Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
Fascin (55k-2) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
FSH Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
FOXA1 (2F83) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
anti-FoxP1 (SP133) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Factor VIII-R Ag. Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
FITC anti-Fibrinogen Primary Antibody
IVD
For in vitro diagnostic use.
Factor XIIIa (EP3372) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
Factor XIIIa (AC-1A1) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
VENTANA anti-E-cadherin (36) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
E-cadherin (EP700Y) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
anti-EGFR E746-A750 del (SP111) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
anti-EGFR L858R (SP125) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Ep-CAM/Epithelial Specific Antigen (Ber-EP4) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Epidermal Growth Factor Receptor (3C6) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Epstein-Barr Virus (CS1-4) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
anti-Epithelial Related Antigen (MOC-31) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Desmoglein 3 (5G11) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
anti-ERG (EPR3864) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
PATHWAY
®
Anti-c-KIT (9.7) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-ALK1 (ALK01) Primary Antibody
IVD
For in vitro diagnostic use.
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody
790-4794
IVD
For in vitro diagnostic use.
DOG1 (SP31) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-ALK1 (ALK01) Primary Antibody
IVD
For in vitro diagnostic use.
anti-CMV Blend (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
For use with VENTANA MMR IHC Panel, OUS, 760-5095
IVD
For in vitro diagnostic use.
VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
For use with VENTANA MMR IHC Panel, US, 790-5095
IVD
For in vitro diagnostic use.
VENTANA Basal Cell Cocktail (34βE12+p63)
IVD
For in vitro diagnostic use.
CONFIRM anti-bcl-2 (124) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
BCA-225 (Cu-18) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
BG8, Lewis
y
(F3) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
BOB.1 (SP92) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
bcl-6 (GI191E/A8) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
Cadherin-17 (SP183) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CA-125 (OC125) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
FITC anti-C1q Primary Antibody
IVD
For in vitro diagnostic use.
FITC anti-C3 Primary Antibody
IVD
For in vitro diagnostic use.
Calcitonin Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
C4d Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
anti-C4d (SP91) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CA19-9 (121SLE) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Carbonic Anhydrase IX (CA IX) (EP161) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
CEA (CEA31) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD138/syndecan-1 (B-A38) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
Calponin-1 (EP798Y) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD14 (EPR3653) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD13 (SP187) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Caldesmon (E89) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD23 (SP23) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD1a (EP3622) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD2 (MRQ-11) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD16 (SP175) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD163 (MRQ-26) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD21 (EP3093) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD21 (2G9) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD34 (QBEnd/10) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD3 (2GV6) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD25 (4C9) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
anti-CD43 (L60) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD33 (SP266) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD31 (JC70) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
anti-CD38 (SP149) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
anti-CD44 (SP37) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD56 (MRQ-42) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD56 (123C3) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD5 (SP19) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD45 (LCA)(2B11 & PD7/26) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD45R (MB1) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD57 (NK-1) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD63 (NKI/C3) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CD61 (2f2) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CINtec
®
Histology Kit
CE
IVD
For in vitro diagnostic use.
CDX-2 (EPR2764Y) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
anti-CD7 (SP94) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD71 (MRQ-48) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CINtec
®
Histology
CINtec® Histology is the only 510(k) p16 immunohistochemistry biomarker test for clinical/IVD use in the evaluation of cervical biopsy specimens.
IVD
For in vitro diagnostic use.
CINtec
®
p16 Histology
CE
IVD
For in vitro diagnostic use.
CINtec
®
p16 Histology
RUO
For Research Use Only. Not for use in diagnostic procedures.
anti-CMV Blend (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Collagen Type IV (CIV22) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
Cytokeratin 19 (A53-B/A2.26) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
Cytokeratin 5/14 (EP1601Y/LL002) Rabbit and Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
COX-2 (SP21) Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
VENTANA anti-Cyclin D1 (SP4-R) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
anti-Cytokeratin 14 (SP53) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Cytokeratin (35betaH11) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
anti-Cytokeratin 10 (SP99) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
anti-Cytokeratin 17 (SP95) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
anti-Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Cytokeratin 5 (SP27) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Cytokeratin 8 & 18 (B22.1 & B23.1) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
FITC anti-Albumin Primary Antibody
IVD
For in vitro diagnostic use.
anti-Cytokeratin (CAM 5.2) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
BenchMark ULTRA PLUS
The BenchMark ULTRA PLUS system uses an unprecedented, fully-automated workflow for immunohistochemistry (IHC) and in-situ hybridization (ISH) slide staining to improve turnaround time and decrease touchpoints.
IVD
For in vitro diagnostic use.
IDH1 R132H (MRQ-67) CM Rabbit Monoclonal Antibody
IVD
For in vitro diagnostic use.
ATRX CM Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
anti-CD8 (SP239) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CD34 (QBEnd/10) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
Cytokeratin (OSCAR) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
SF-1 (EP434) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody
741-7155
IVD
For in vitro diagnostic use.
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody
741-7157
IVD
For in vitro diagnostic use.
CINtec
®
Histology Kit
FDA
IVD
For in vitro diagnostic use.
Beta-Catenin (14) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
MUC2 (MRQ-18) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
CONFIRM™ anti-c-KIT (9.7) Primary Antibody
IVD
For in vitro diagnostic use.
Red Counterstain II
IVD
For in vitro diagnostic use.
Mucicarmine Staining Kit
IVD
For in vitro diagnostic use.
Special Stains Van Gieson CS
IVD
For in vitro diagnostic use.
Reticulum II Staining Kit
IVD
For in vitro diagnostic use.
Trichrome Staining Kit
IVD
For in vitro diagnostic use.
PAS Staining Kit
IVD
For in vitro diagnostic use.
Giemsa Staining Kit
IVD
For in vitro diagnostic use.
Green for Trichrome
IVD
For in vitro diagnostic use.
Gram Staining Kit
IVD
For in vitro diagnostic use.
GMS II Staining Kit
IVD
For in vitro diagnostic use.
BenchMark Special Stains AFB Staining Kit
IVD
For in vitro diagnostic use.
Jones Light Green Staining Kit
IVD
For in vitro diagnostic use.
Elastic Stain Core Kit
IVD
For in vitro diagnostic use.
Congo Red Staining Kit
IVD
For in vitro diagnostic use.
Light Green for PAS
IVD
For in vitro diagnostic use.
Jones Staining Kit
IVD
For in vitro diagnostic use.
Iron Staining Kit
IVD
For in vitro diagnostic use.
Diastase Kit
IVD
For in vitro diagnostic use.
WT1 (6F-H2) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
Alcian Blue for PAS
IVD
For in vitro diagnostic use.
Alcian Blue Staining Kit
IVD
For in vitro diagnostic use.
CONFIRM anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
FITC anti-Kappa Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Kappa Rabbit Polyclonal Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Keratin (34βE12) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
FITC anti-IgA Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Vimentin (V9) Primary Antibody
IVD
For in vitro diagnostic use.
anti-NSE (MRQ-55) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Desmin (DE-R-11) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Lambda Rabbit Polyclonal Primary Antibody
IVD
For in vitro diagnostic use.
FITC anti-Lambda Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-S100 (Polyclonal) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD99 (O13) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
anti-Chromogranin A (LK2H10) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD79a (SP18) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD4 (SP35) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD45, LCA (RP2/18) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD68 (KP-1) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD20 (L26) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-CD15 (MMA) Mouse Monoclonal, Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-p53 (DO-7) Primary Antibody
IVD
For in vitro diagnostic use.
Protease 3
IVD
For in vitro diagnostic use.
anti-p53 (Bp53-11) Primary Antibody
IVD
For in vitro diagnostic use.
Protease 1
IVD
For in vitro diagnostic use.
anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody
IVD
For in vitro diagnostic use.
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
ultra
View Red ISH DIG Detection Kit
IVD
For in vitro diagnostic use.
ultra
View SISH DNP Detection Kit
GLU
For general laboratory use.
VENTANA Connect middleware
VENTANA Connect middleware is software that links your existing Laboratory Information System (LIS) with the entire portfolio of Roche Tissue Diagnostics instruments and systems.
IVD
For in vitro diagnostic use.
anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody
PRAME (PReferentially expressed Antigen in MElanoma) is a tumor biomarker expressed in most cutaneous and ocular melanomas.
IVD
For in vitro diagnostic use.
Hematoxylin II
IVD
For in vitro diagnostic use.
C3d Rabbit Polyclonal Antibody
IVD
For in vitro diagnostic use.
VENTANA
®
CLDN18 (43-14A) Assay
IVD
For in vitro diagnostic use.
PD-1 (NAT105) Mouse Monoclonal Antibody
IVD
For in vitro diagnostic use.
PATHWAY anti-HER-2/
neu
(4B5) Rabbit Monoclonal Primary Antibody
PATHWAY HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, one of over 250 optimized pre-diluted reagents for use on the BenchMark IHC/ISH automated slide staining instruments by Roche Diagnostics.
IVD
For in vitro diagnostic use.
VENTANA HER2 Dual ISH DNA Probe Cocktail
US Export
The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is a fully automated, ready-to-use brightfield solution for determining HER2 gene status.
GLU
For general laboratory use.
ISH Amplification Kit
IVD
For in vitro diagnostic use.
VENTANA
®
DLL3 (SP347) Assay
IVD
For in vitro diagnostic use.
CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
VENTANA
®
Red ISH DIG Detection Kit
IVD
For in vitro diagnostic use.
anti-CD117 (EP10) Rabbit Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
VENTANA
®
PD-L1 (SP142) Assay
US-FDA
VENTANA PD-L1 (SP142) Assay is intended for the qualitative immunohistochemical assessment of the programmed death ligand 1 (PD-L1) protein.
IVD
For in vitro diagnostic use.
OptiView Amplification Kit
IVD
For in vitro diagnostic use.
anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody
IVD
For in vitro diagnostic use.
Steiner II Staining Kit
IVD
For in vitro diagnostic use.
VENTANA
®
HER2 Dual ISH DNA Probe Cocktail
US-FDA
The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is a fully automated, ready-to-use brightfield solution for determining HER2 gene status.
IVD
For in vitro diagnostic use.
VENTANA
®
ALK (D5F3) CDx Assay
US-FDA
The VENTANA ALK (D5F3) CDx Assay empowers your lab to provide timely results with a four-and-one-half hour run time using fully automated, ready-to-use reagents.
IVD
For in vitro diagnostic use.
VENTANA HE 600 Hematoxylin
IVD
For in vitro diagnostic use.
VENTANA HE 600 Eosin
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (CE IVD)
VENTANA MMR RxDx Panel (CE IVD)
Lung cancer IHC panel
VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (CE IVD)
Hematopathology cancer IHC/ISH panel
Dermatopathology IHC panel
Breast cancer IHC/ISH portfolio
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