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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2001-03-06 |
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