FDA Registration Active 🇺🇸 United States

Ionify iDIL cobas i

Reg #: 2028492 · FEI: 1000125183 · Expires 2025
Products
1
Proprietary Names
292
Establishment Types
2
Classifications
1

Registration Details

Registration Name
VENTANA MEDICAL SYSTEMS, INC.
Registration Number
2028492
FEI Number
1000125183
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1910 EAST INNOVATION PARK DR.
City
Tucson
State
AZ
ZIP
85755
Country
US

Owner / Operator

Firm Name
Roche Diagnostics Operations Inc.
Operator Number
9039767
Address
9115 Hague Road
City
Indianapolis
State
IN
Postal Code
46250
Country
US

Products

Device Name Product Code
General Purpose Reagent PPM

Proprietary Names

Ionify iDIL cobas i MPLC RNA Isol.Tissue Lysis Buffer Refill NACl 9% SI Gen.2, cobas c, Integra ISE Reference Electrolyte 500ML cobas Integra Cleaner EcoTergent LC EBV Rec Template MPC Nucleic Acid Isol. Kit I Large Vol. LC DNA Master Hy. Pb, 96 react. LC HSV 1/2 Template DNA MagNA Pure LC tNA Isol. Kit HP dCTP,PCR Grade Di-Na solution COBAS INTEGRA ISE ETCHER 6 x 11ML Ionify SysR S3 cobas i 1x1L Ionify Mass Axis Solution (iAxisSol) Ionify Pretreatment Whole Blood (iPTWB) Ionify System Reagent S1 (iSysR S1) MPLC Sample Cartridges LC Multiplex DNA Master HP MPLC DNA Isol. Kit I Probe Wash M Elecsys,cobas e MPLC DNA Isol.KitI-Lysis/Bind.Buf.Refill cobas C SPECIAL CELL CLEANING SOLUTION ECL-LC, BV-CLEAN Plus, 1000ml ProCell Elecsys,cobas e MPLC mRNA HS Kit MPLC RNA Isol. Kit High Performance RealTime ready RNA Virus Master HP PCR Template Preparation Kit HITACHI ISE 1N KCL ELECT SOLUTION 1L Ionify System Reagent VB2 (iSysR V2) Ionify Deproteinizer iDepro (6x21ML) CLEANING SOLUTION 988-4 (125 ML) S.E.T.S. ISE ETCHER cobas c 111 system NaOH-D, cobas c 701 HP Viral Nucleic Acid Kit Ionify SysR VB2 cobas i 4x500ml Ionify SysR VB1 cobas i 4x500ml MPLC Waste Bottle NaOH-D, cobas c CleanCell M 2x2 L Elecsys,cobas e Elecsys SYSCLEAN MPLC Processing Cartridges PCR-M Elution Buffer 50mM pH 8,1, MBF MPLC Waste Bag Universal Diluent 2x36ml Elecsys,cobas e NACl 9% Dil, cobas c Acid wash Solution 2x1,8 L SMS Solution for HIT 917 Ionify iPTWB cobas i MPLC Reaction Tip (large) SET STREPTAVIDIN PHYCOERYTHRIN 1mL LUO ISE DEPROTEINIZER cobas c 111 system MPLC Tub Lid Seal LC FS DNA Master^PLUS Hy.Pb, 480 react. S.E.T.S. II Kit Ionify iDR1 cobas i Ionify SysR S4 cobas i 1x1L Ionify System Reagent VB1 (iSysR V1) MPLC O-Ring Maintenance Kit Sample Cleaner 2, cobas 8000 cobas Integra FP Sample Dilution Ionify Pretreatment 1 (iPT1) LC FS DNA Master Hy.Pb., 96 react. MPLC Disposable MPLC mRNA Isol. Kit I - Lysis Buf.Refill ISE Diluent Gen.2, 2x2 Liter CleanCell Elecsys,cobas e RINSE ADDITIVE SOLUTION (100x1 ML) NaCL 9% cobas c 111 LC Multicolor Demo Set MP Bacteria Lysis Buffer ISE DEPROTEINIZER cobas integra (6x21ML) Ionify System Reagent VB4 (iSysR V4) Ionify Pretreatment 2 (iPT2) Ionify SysR VB3 cobas i 4x500ml MPLC Reaction Tip (small) SMS, cobas c NaOH-D/Basic Wash 2x1,8 L FLUID PACK S2 (1 PC) Hitergent c311 ECL-LC, BV-DILUENT, 250ml BlankCell Elecsys,cobas e LC DNA Master Hy.Pb, 480 react. LC Strep B PTS1 GPR GC-RICH PCR System 2.2 KU Accelerator I 1 x 100ML Diluent MultiAssay Elecsys,cobas e ISE Diluent Gen.2, cobas c, Hitachi cobas Integra NACl Diluent 9 % PCR ENZYME, CUSTOM SQNM dATP,PCR Grade Di-Na Solution 4x125 uM LIGHTCYCLER MULTIPLEX DNA MASTER, 1000 rx dUTP, PCR Grade, 25 umol dCTP,PCR Grade Di-Na Solution 4x125 uM dUTP,PCR Grade Di-Na Solution 4x125 uM LightCycler Capillaries 100ul,M-grade PCR Enzyme, custom SQNM 1250 units dTTP,PCR Grade Di-Na Solution 4x125 uM Phosphatase,alkaline(AP),MB grd.(20U/ul) dTTP, PCR Grade, 125 umol PCR Buffer (10x) with MgCl2 GPR LC Capillaries (100 ul) Phosphatase,alkaline(AP),MB Grade(1U/ul) dTTP, PCR Grade, 25 umol SAP Test Elecsys,cobas e LCS (Predilute) ELECSYS SAP BUFFER LC FS DNA MasterPLUS HP, 100 ul ultraView SISH Detection Kit ISH Negative Control BenchMark Special Stains Deparaffinization Solution (10X) Alu Positive Control Probe II Special Stains Vapor Extraction System RNA Positive Control Probe VENTANA HE 600 Transfer Fluid VENTANA HE 600 Cleaning Solution VENTANA HE 600 Organic Solution LIGHTCYCLER MULTIPLEX DNA MASTER, 200 rx Special Stains Cleaning Kit ProCell M G2 2x2L Elecsys E2G VENTANA HE 600 Bluing LC EvoScript RNA SYBR Green Master 1000 Special Stains Heavy Metal Extraction System HybReady Solution Hemolyzing reagent f.TQ HBA1c,cobas c513 Clean Cell M 2x2L Elecsys, cobas e LC EvoScript RNA SYBR Green Master (200) LightCycler EvoScript RNA Probes Master, 200 Reactions PreClean M G2 2x2L Elecsys E2G LC EvoScript RNA Probes Master (200) LightCycler EvoScript RNA Probes Master, 1000 Reactions Antibody Dilution Buffer LightCycler EvoScript RNA SYBR Green Master 1000 ultraView Red ISH DIG Detection Kit VENTANA HE 600 Coverslip Activator EZ Prep Concentrate (10X) ultraView Alkaline Phosphatase Red ISH Detection Kit VENTANA ISH iVIEWBlue Plus Detection Kit LightCycler EvoScript RNA SYBR Green Master 200 ISH Amplification Kit BenchMark Special Stains Liquid Coverslip ultraView SISH DNP Detection Kit VENTANA HE 600 Differentiating Solution Special Cell Cleaning Solution, c513 MagNA Pure 24 Total NA Isolation Kit Cell Wash Solution I/NaOH-D 2x1.9L VENTANA HE 600 Wash VENTANA ISH iVIEWBlue Detection Kit ultraView Silver Wash II Diluent MultiAssay E2G ISH Peroxidase Inhibitor Diluent Universal E2G KIT COBAS 6800/8800 HEV 96T CE-IVD MagNA Pure 24 MGP set ULTRA LCS (Predilute) Acid wash Solution 2x2 L cobas c 70x KCL/500 mL VENTANA BenchMark Special Stains Wash II ISE Reference Electrolyte, 2L KIT ELECSYS CLEAN-CELL M 2X2 L cobas® Sample Prep Buffer EcoTergent, cobas c503 SCCS, 50Tests, cobas c503 Hemolyzing reagent KIT COBAS 58/68/88 UTIL CHAN 192T IVD cobas® PCR Media KIT COBAS PRIME SAMPLE PREP BUFFER IVD BASIC WASH 2x2 L S3 FLUID PACK A (1 PC) ISE Reference Electrolyte MagNa Pure 96 System Fluid S1 RINSE SOLUTION (2 PCS) S2 FLUID PACK (1 PC) A1CD, cobas c 503 CLEANING KIT for CL- ELECTRODE cobas® Sample Prep Buffer (CSPB) SMS, cobas c503, 123T SARS-CoV-2 Inactivation Solution UTM/VTM NaOH-D, 123Tests, cobas c503 Special Cell Cleaning Solution Antigen Excess Reagent PYP, 950T, cobas c 503 NACl 9% SI Gen.2, 14500Tests, cobas c503 NaCl or Sodium Chloride Acid Wash Solution Serum Index Gen.2 KIT COBAS PRIME PCR MEDIA IVD NaOH-D or Sodium Chloride Detergent NACl 9% Dil, cobas c503, 123T SARS-CoV-2 Inactivation Solution KIT COBAS PRIME SPEC PRE-EXTRACTION IVD Pyridoxal phosphate Special Wash Solution cobas® Specimen Pre-Extraction Reagent cobas® Specimen Pre-Extraction Reagent (SPER) START, 1000T, cobas c 503 cobas omni Utility Channel (192T) LC Multiplex RNA Virus Master, 1000 Eco Detergent LC Multiplex RNA Virus Master, 200 Benchmark Special Stains Cleaning Kit Digital LightCycler® DNA Master Kit Digital LightCycler® Partitioning Fluid DNA AWAY High Pure PCR Template Preparation Kit cobas c 70X Internal Standard/2000 mL ISE Int.Stand. Gen.2, cobas c, Hitachi Digital LightCycler® RNA Master Kit High Pure Viral RNA Kit Ionify Deproteinizer (iDEPRO) M-MLV RT, Mutante 3 Ionify Diluent 1 (iDIL1) URINE DILUENT (500 ML) Cleaner Basisch cobas c111 NucleoMix, 25mmol/l, 0.6 ml, GPR Ionify iPTReag1 cobas i Ionify System Reagent CS (iSysR CS) SODIUM ELECTRODE CONDITIONER (125 ML) MagNA Pure Compact RNA Isolation Kit High Pure Viral NA Large Volume Kit Ionify AxisSol cobas i 1x500ml Ionify System Reagent S2 (iSysR S2) High PureViral Nucleic Acid Kit Ionify System Reagent VB3 (iSysR V3) MagNA Lyser Green Beads MPC Nucleic Acid Isolation Kit I Sample Cleaner 1, cobas 8000 LC FastStart Master Hyb Probes, M-Grade HP Viral Nucleic Acid Buffer Set dGTP, PCR Grade cobas Integra Cleaner 150Tests LC RNA Amplification Kit, Hyb. Probes CLEANING SOLUTION FOR AVL COMPACT II MPLC RNA Isol. Kit III Tissue SMS, cobas c 701 HP Viral RNA Kit Ionify SysR VB4 cobas i 1x500ml Ionify SysR S1 cobas i 4x500ml S.T.A.R. Hybridization Wash Buffer Kit dATP,PCR Grade Di-Na solution MPLC Tub Lid (small, medium) MPLC Total NA Isolation Kit-Large Volume LC Uracil-DNA Glycosylase ECL-LC, BV-SANITIZE, 100ml Uracil-DNA Glycosylase,Heat-labile,500 U LC Control Kit RNA Ionify SysR CS cobas i 1x1L Ionify System Reagent S3 (iSysR S3) PreClean M Elecsys,cobas e MPLC DNA Isol. Kit II (Tissue) ProCell M 2x2 L Elecsys,cobas e NaOH-D / Basic Wash MPLC Reagent Tub (small) MPLC DNA Isol. Kit III (Bacteria) LC FS DNA Master^PLUS HY-Pb, 96 react. LightCycler Capillaries (20ul) 5x96 ECL-LC, BV-STORE, 250ml Uracil-DNA Glycosylase,Heat-labile,100 U LC Control Kit DNA Ionify iPTReag2 cobas i MPLC Reagent Tub (medium) MPLC totalNA Isol.Kit-Lysis/Bind.Buf.Ref LC CD Manual complete SW 4.1 ECL-LC, BV-GLO Plus, 1000ml PCR Buffer without MgCl_2 , 10 x DEPROTEINIZER (125 ML) MagNA Pure DNA Tissue Lysis Buffer Hitergent cobas c701 Cell Check Elecsys,cobas e MPLC Total Nucleic Acid Isolation Kit Sample Cleaner 1, cobas c LC RNA Master Hybridization Probes LC QC Kit Activator for cobas c,Integra,c111 Ionify Derivatization Reagent 1 (iDR1) Ionify SysR S2 cobas i 1x1L Ionify System Reagent S4 (iSysR S4) MPLC Cartridge Seal Terminal Transferase, recomb. (24 000 U) NACl 9% SI Gen.2, 3000Tests cobas c701 dCTP,PCR Grade Di-Na slt OMNI SOLUTION 2 (4x40 ML) Terminal Transferase,recombinant (8000U) NACl 9% Dil, cobas c 701 Sys Wash Elecsys,cobas e MPLC DNA Isol. Kit Large Volume MPLC Greasing Set Sample Cleaner 2, cobas 6000 LC FS DNA Master Hy.Pb, 480 react.

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility