VENTANA MEDICAL SYSTEMS, INC.

FDA Device Registration & Listing · Tucson, AZ, US · Registration 2028492

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2028492
FEI Number
1000125183
Entity Name
VENTANA MEDICAL SYSTEMS, INC.
City/State/Country
Tucson, AZ, US
Establishment Address
1910 EAST INNOVATION PARK DR., Tucson, AZ 85755, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Roche Diagnostics Operations Inc. (Owner Number: 9039767)
Owner / Operator Contact Address
9115 Hague Road, Indianapolis, IN 46250, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K140465
PMA Number
N/A

All Registered Proprietary Names

Special Stains Van Gieson CS TOP2A ISH Xenograft Control Slides HPV Family 6 System Control Slides (B) HPV 3 in 1 System Control Slides PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antib PATHWAY HER-2 4 in 1 Control Slides PATHWAY Anti-c-KIT (9.7) Primary Antibody Gram Staining Kit Giemsa Staining Kit INFORM HER2 Dual ISH DNA Probe Cocktail NEXES VEN IVIEW DAB DET KT JPN-US Export VENTANA PD-L1 (SP263) CE IVD US Export CINtec PLUS Cytology Kit (CE IVD) CINtec PLUS Cytology Kit (US-Export) VEN anti-HER2/neu [4B5] RM PAB-US EXPORT VENTANA ROS1 (SP384) Assay US Export VENTANA CLDN18 (43-14A) RxDx Assay W VENTANA EBER Probe VENTANA CLDN18 (43-14A) RxDx Assay VENTANA PD-L1 (SP142) Assay W VENTANA PD-L1 (SP142) Assay Alcian Blue for PAS Alcian Blue Staining Kit CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody Lambda DNP Probe (768-797) HPV 18 mRNA Probe Lambda DNP Probe (704-733) EGFR DNP Probe HPV 33 mRNA Probe Kappa DNP Probe (597-626) HPV 16 mRNA Probe Chromosome 7 DIG Probe HPV 11 mRNA Probe Kappa DNP Probe (538-567) Chromosome 12 DIG Probe Lambda DNP Probe (664-693) Kappa DNP Probe (495-524) Kappa DNP Probe (637-666) Lambda DNP Probe (826-855) EBER 1 DNP Probe U6 DNP Probe HPV 6 mRNA Probe EBER1 DIG Probe Iron Staining Kit BenchMark Special Stain AFB Staining Kit VENTANA KAPPA LAMBDA DISH mRNA PRB Congo Red Staining Kit Elastic Staining Kit CINtec p16 Histology Temperature Verifier Slides DigiMAC3 Slides OLR1 (FOLR1-2.1) RxDx Assay US EXPORT PAS Staining Kit PAS Stain Core Kit VEN HER2 (4B5) RM PAB RxDx W VENTANA DP 200 slide scanner (IVD) Roche Digital Pathology Dx (VENTANA DP 200) VENTANA HE 600 Glass Coverslips VENTANA PTEN (SP218) RxDx Assay Jones Staining Kit GMS II Staining Kit Jones Light Green Staining Kit cobas p 680 START-UP KIT MagNA Pure 24 Tip Park/Piercing Tool MagNA Pure 24 Piercing Tool MagNa Pure Compact Drip Tray MagNa Pure Lyser Rotor Lightcycler 2 Centrifuge MPLC CB, Reaction Tubes MP Compact Waste Tank MagNa Pure Compact Drop catcher Lightcycler O-Ring Cell Set cobas C311 AVENIO MILLISECT System SW cobas omni UCT 3.1 Lightcycler Color Compensation Set MagNa Pure RXN TIPS-LARGE Clot Catcher Pro [100 PCS] MagNa Pure LC Cool Block, Sample Carousel PC/CC-CUPS MagNa Pure Compact Tube Rack MPLC CB, 96-well PCR Plate MagNa Pure REAGENT TUB LID (Large) MagNa Lyser 115V MagNa Pure Waste accessories MagNa Pure Compact Cartridge Rack MagNa Pure LC 2 Instrument LIGHTCYCLER CLASSIC ROTOR UPGRADE KIT CLOT CATCHER [250 PC] MagNa Pure Compact Elution Tube Rack MPLC Reaction Tip (small) MPLC Greasing Set MPLC Reagent Tub (SMALL) MagNa Pure 96 Waste Rack IVD MPLC TUB LID (Small, Medium) Avenio Millisect System 2 MPLC Tub Lid (Large) MPLC O-Ring Maintenance Kit CONA, 100Tests, cobas c503 MagNa Pure 96 Reagent Rack IVD MPLC TUB LID SEAL Carry-over Needle Assessment MagNa Pure 96 Purification Rack IVD ISD Sample PT Elecsys cobas e 100 MagNa Pure Liquid Waste Funnel REFERENCE ELECTRODE ISE 91XX cobas Omni Processing Plate MICRO ELECTRODE REF MagNa Pure 96 Processing Plate cobas Omni Pipette Tips Instrument Check cobas Omni Amplification Plate MagNa Pure 96 Processing Cartridge MagNa Pure 96 Output Plate AssayTip/AssayCup tray ControlSet Vials Elecsys,cobas e LIGHTCYCLER ACCESSORIES CalSet Vials Elecsys,cobas e MagNA Pure 96 Dropcatcher IVD MAGNAPURE ACCESSORIES VENTANA HE 600 Hematoxylin Hematoxylin II Hematoxylin Elastic Stain Core Kit Special Stains Hematoxylin MSH2 (G219-1129) MM PAB MLH1 (M1) MM PAB MSH6 (SP93) RM PAB BRAF V600E (VE1) MM PAB PMS2 (A16-4) MM PAB CINtec HISTOLOGY (250) CINtec HISTOLOGY (50) VENTANA MET (SP44) RxDx Assay STEINER II STAINING KIT INFORM HPV III Family 16 Probe (B) INFORM HPV II Family 6 Probe KIT cobas 4800 HPV AMP/DET 960T CE-IVD KIT cobas 4800 HPV AMP/DET 240T CE-IVD Light Green for PAS Special Stains Light Green CS Diastase Kit Mucicarmine Staining Kit Special Stains Tartrazine CS ALK (D5F3) VENTANA HER2 Dual ISH DNA Probe Cocktail SSR Solution Gram Stain Core Kit VENTANA CLDN18 (43-14A) RxDx Assay PreClean M Elecsys,cobas e MPLC RNA Isol.Tissue Lysis Buffer Refill ProCell M 2x2 L Elecsys,cobas e MagNA Pure LC tNA Isol. Kit HP Ionify SysR S3 cobas i 1x1L MPLC DNA Isol. Kit III (Bacteria) LC FS DNA Master^PLUS HY-Pb, 96 react. MagNA Pure DNA Tissue Lysis Buffer LC Control Kit DNA Ionify SysR CS cobas i 1x1L MPLC Tub Lid (small, medium) dGTP, PCR Grade Cleaner Basisch cobas c111 NucleoMix, 25mmol/l, 0.6 ml, GPR EcoTergent Ionify SysR VB1 cobas i 4x500ml Ionify System Reagent CS (iSysR CS) Ionify System Reagent VB1 (iSysR V1) Ionify AxisSol cobas i 1x500ml Ionify System Reagent S2 (iSysR S2) Ionify Pretreatment Whole Blood (iPTWB) Ionify System Reagent S1 (iSysR S1) LC HSV 1/2 Template DNA LC QC Kit Activator for cobas c,Integra,c111 LC CD Manual complete SW 4.1 dCTP,PCR Grade Di-Na solution COBAS INTEGRA ISE ETCHER 6 x 11ML MPLC Total Nucleic Acid Isolation Kit ECL-LC, BV-DILUENT, 250ml LC Uracil-DNA Glycosylase ISE ETCHER cobas c 111 system LC Control Kit RNA MPLC RNA Isol. Kit High Performance ISE DEPROTEINIZER cobas c 111 system HITACHI ISE 1N KCL ELECT SOLUTION 1L Terminal Transferase,recombinant (8000U) NACl 9% SI Gen.2, cobas c, Integra Sys Wash Elecsys,cobas e cobas Integra Cleaner MPLC mRNA Isol. Kit I - Lysis Buf.Refill CleanCell Elecsys,cobas e HP Viral Nucleic Acid Buffer Set CLEANING SOLUTION 988-4 (125 ML) S.E.T.S. NaOH-D, cobas c HP Viral Nucleic Acid Kit SODIUM ELECTRODE CONDITIONER (125 ML) MPLC mRNA HS Kit RealTime ready RNA Virus Master HP PCR Template Preparation Kit MPLC Waste Bag Universal Diluent 2x36ml Elecsys,cobas e SMS Solution for HIT 917 RINSE ADDITIVE SOLUTION (100x1 ML) ECL-LC, BV-STORE, 250ml Uracil-DNA Glycosylase,Heat-labile,100 U URINE DILUENT (500 ML) MPLC Total NA Isolation Kit-Large Volume ECL-LC, BV-SANITIZE, 100ml Uracil-DNA Glycosylase,Heat-labile,500 U MPLC DNA Isol. Kit I Probe Wash M Elecsys,cobas e cobas C SPECIAL CELL CLEANING SOLUTION ECL-LC, BV-CLEAN Plus, 1000ml MPLC Processing Cartridges PCR-M Elution Buffer 50mM pH 8,1, MBF NaOH-D, cobas c 701 Sample Cleaner 2, cobas 8000 DEPROTEINIZER (125 ML) MPLC DNA Isol. Kit Large Volume SMS, cobas c Sample Cleaner 2, cobas 6000 Cell Check Elecsys,cobas e MPLC Reaction Tip (large) CLEANING SOLUTION FOR AVL COMPACT II SET STREPTAVIDIN PHYCOERYTHRIN 1mL LUO SMS, cobas c 701 GC-RICH PCR System 2.2 KU PCR ENZYME, CUSTOM SQNM dTTP, PCR Grade, 125 umol PCR Buffer (10x) with MgCl2 GPR dUTP, PCR Grade, 25 umol LC FS DNA MasterPLUS HP, 100 ul PCR Enzyme, custom SQNM 1250 units dUTP,PCR Grade Di-Na Solution 4x125 uM LC Capillaries (100 ul) Phosphatase,alkaline(AP),MB Grade(1U/ul) Phosphatase,alkaline(AP),MB grd.(20U/ul) dCTP,PCR Grade Di-Na Solution 4x125 uM ELECSYS SAP BUFFER SAP Test Elecsys,cobas e LIGHTCYCLER MULTIPLEX DNA MASTER, 1000 rx dATP,PCR Grade Di-Na Solution 4x125 uM LightCycler Capillaries 100ul,M-grade dTTP,PCR Grade Di-Na Solution 4x125 uM Cell Wash Solution I/NaOH-D 2x1.9L LIGHTCYCLER MULTIPLEX DNA MASTER, 200 rx dTTP, PCR Grade, 25 umol LC EvoScript RNA Probes Master (200) ultraView Alkaline Phosphatase Red ISH Detection Kit VENTANA HE 600 Coverslip Activator EZ Prep Concentrate (10X) VENTANA HE 600 Cleaning Solution ULTRA LCS (Predilute) BenchMark Special Stains Deparaffinization Solution (10X) MagNA Pure 24 MGP set VENTANA HE 600 Differentiating Solution ISH Amplification Kit VENTANA HE 600 Wash VENTANA HE 600 Bluing LightCycler EvoScript RNA Probes Master, 200 Reactions LightCycler EvoScript RNA SYBR Green Master 200 HybReady Solution Hemolyzing reagent f.TQ HBA1c,cobas c513 LightCycler EvoScript RNA Probes Master, 1000 Reactions LCS (Predilute) LC EvoScript RNA SYBR Green Master 1000 LightCycler EvoScript RNA SYBR Green Master 1000 Special Stains Vapor Extraction System Special Stains Cleaning Kit VENTANA HE 600 Organic Solution VENTANA ISH iVIEWBlue Detection Kit ultraView SISH DNP Detection Kit LC EvoScript RNA SYBR Green Master (200) Special Cell Cleaning Solution, c513 Clean Cell M 2x2L Elecsys, cobas e Antibody Dilution Buffer ISH Peroxidase Inhibitor Special Stains Heavy Metal Extraction System PreClean M G2 2x2L Elecsys E2G RNA Positive Control Probe ultraView SISH Detection Kit MagNA Pure 24 Total NA Isolation Kit VENTANA ISH iVIEWBlue Plus Detection Kit ultraView Red ISH DIG Detection Kit KIT COBAS 6800/8800 HEV 96T CE-IVD Alu Positive Control Probe II ultraView Silver Wash II BenchMark Special Stains Liquid Coverslip ISH Negative Control ProCell M G2 2x2L Elecsys E2G Diluent MultiAssay E2G Diluent Universal E2G VENTANA HE 600 Transfer Fluid Acid wash Solution 2x2 L VENTANA BenchMark Special Stains Wash II S1 RINSE SOLUTION (2 PCS) cobas c 70x KCL/500 mL KIT ELECSYS CLEAN-CELL M 2X2 L Antigen Excess Reagent S3 FLUID PACK A (1 PC) CLEANING KIT for CL- ELECTRODE NaOH-D, 123Tests, cobas c503 Serum Index Gen.2 NACl 9% Dil, cobas c503, 123T PYP, 950T, cobas c 503 Special Cell Cleaning Solution EcoTergent, cobas c503 Special Wash Solution S2 FLUID PACK (1 PC) cobas® Sample Prep Buffer (CSPB) START, 1000T, cobas c 503 Eco Detergent SCCS, 50Tests, cobas c503 Acid Wash Solution Pyridoxal phosphate KIT COBAS PRIME SPEC PRE-EXTRACTION IVD ISE Reference Electrolyte, 2L SMS, cobas c503, 123T Hemolyzing reagent ISE Reference Electrolyte KIT COBAS PRIME PCR MEDIA IVD BASIC WASH 2x2 L NaCl or Sodium Chloride cobas® Specimen Pre-Extraction Reagent (SPER) NACl 9% SI Gen.2, 14500Tests, cobas c503 NaOH-D or Sodium Chloride Detergent cobas® PCR Media A1CD, cobas c 503 cobas® Sample Prep Buffer LC Multiplex RNA Virus Master, 200 LC Multiplex RNA Virus Master, 1000 SARS-CoV-2 Inactivation Solution UTM/VTM KIT COBAS PRIME SAMPLE PREP BUFFER IVD SARS-CoV-2 Inactivation Solution MagNa Pure 96 System Fluid cobas® Specimen Pre-Extraction Reagent cobas omni Utility Channel (192T) KIT COBAS 58/68/88 UTIL CHAN 192T IVD Benchmark Special Stains Cleaning Kit High Pure PCR Template Preparation Kit M-MLV RT, Mutante 3 Digital LightCycler® Partitioning Fluid Digital LightCycler® RNA Master Kit Digital LightCycler® DNA Master Kit High Pure Viral RNA Kit Ionify iPTReag2 cobas i Ionify SysR VB4 cobas i 1x500ml Ionify SysR S1 cobas i 4x500ml DNA AWAY Ionify Mass Axis Solution (iAxisSol) Ionify SysR VB2 cobas i 4x500ml Ionify Deproteinizer iDepro (6x21ML) Ionify Derivatization Reagent 1 (iDR1) Ionify System Reagent VB3 (iSysR V3) Ionify iDIL cobas i Ionify System Reagent S4 (iSysR S4) Ionify System Reagent VB4 (iSysR V4) Ionify SysR VB3 cobas i 4x500ml Ionify System Reagent VB2 (iSysR V2) Ionify iPTWB cobas i Ionify iPTReag1 cobas i HypoCleaner High PureViral Nucleic Acid Kit Ionify Pretreatment 1 (iPT1) Ionify SysR S2 cobas i 1x1L MPLC Greasing Set NaOH-D/Basic Wash 2x1,8 L LC FS DNA Master Hy.Pb, 480 react. cobas c 70X Internal Standard/2000 mL S.T.A.R. LC Multicolor Demo Set MP Bacteria Lysis Buffer dATP,PCR Grade Di-Na solution ISE DEPROTEINIZER cobas integra (6x21ML) ISE Int.Stand. Gen.2, cobas c, Hitachi Ionify System Reagent S3 (iSysR S3) MPLC Sample Cartridges LC Multiplex DNA Master HP Hitergent cobas c701 MPLC RNA Isol. Kit III Tissue NACl 9% Dil, cobas c HP Viral RNA Kit MagNA Lyser Green Beads MPC Nucleic Acid Isolation Kit I Sample Cleaner 1, cobas c Hitergent c311 cobas Integra Cleaner 150Tests MPLC Reagent Tub (small) MPC Nucleic Acid Isol. Kit I Large Vol. NaCL 9% cobas c 111 LightCycler Capillaries (20ul) 5x96 LC FS DNA Master Hy.Pb., 96 react. MPLC Disposable ISE Diluent Gen.2, 2x2 Liter Sample Cleaner 1, cobas 8000 MPLC Waste Bottle MPLC Cartridge Seal NACl 9% SI Gen.2, 3000Tests cobas c701 Elecsys SYSCLEAN MPLC DNA Isol.KitI-Lysis/Bind.Buf.Refill LC EBV Rec Template ProCell Elecsys,cobas e LC DNA Master Hy. Pb, 96 react. Ionify iDR1 cobas i Ionify SysR S4 cobas i 1x1L MPLC Reaction Tip (small) OMNI SOLUTION 2 (4x40 ML) NACl 9% Dil, cobas c 701 ISE Reference Electrolyte 500ML MPLC Reagent Tub (medium) LC RNA Master Hybridization Probes ECL-LC, BV-GLO Plus, 1000ml MPLC Tub Lid Seal S.E.T.S. II Kit High Pure Viral NA Large Volume Kit MPLC DNA Isol. Kit II (Tissue) NaOH-D / Basic Wash Terminal Transferase, recomb. (24 000 U) Diluent MultiAssay Elecsys,cobas e ISE Diluent Gen.2, cobas c, Hitachi dCTP,PCR Grade Di-Na slt cobas Integra NACl Diluent 9 % Ionify Diluent 1 (iDIL1) Ionify Deproteinizer (iDEPRO) MPLC totalNA Isol.Kit-Lysis/Bind.Buf.Ref LC FastStart Master Hyb Probes, M-Grade PCR Buffer without MgCl_2 , 10 x LC RNA Amplification Kit, Hyb. Probes MPLC O-Ring Maintenance Kit CleanCell M 2x2 L Elecsys,cobas e cobas Integra FP Sample Dilution FLUID PACK S2 (1 PC) LC FS DNA Master^PLUS Hy.Pb, 480 react. MagNA Pure Compact RNA Isolation Kit BlankCell Elecsys,cobas e LC DNA Master Hy.Pb, 480 react. LC Strep B PTS1 GPR Acid wash Solution 2x1,8 L Hybridization Wash Buffer Kit Accelerator I 1 x 100ML Ionify Pretreatment 2 (iPT2) Special Stains Aniline Blue CS BenchMark GX system BenchMark XT system BenchMark ULTRA system BenchMark Special Stains System VENTANA HE 600 system PC ASSEMBLY, VENTANA HE 600 VENTANA HE 600 v1.9.2 Installer VSS 12.5.2 Software Update Installer HE 600 1.9.4 Software Update Installer Software Supplement S Trichrome HE 600 1.9.5 Software Update Installer VENTANA HE 600 V1.10 Installer BenchMark ULTRA PLUS Instrument BENCHMARK ULTRA PLUS INSTRUMENT MLH1 (M1) Mouse Monoclonal PAB PMS2 (A16-4) Mouse Monoclonal PAB MSH2 (G219-1129) Mouse Monoclonal PAB MSH6 (SP93) Rabbit Monoclonal PAB KIT COBAS 4800 HXV CONTROLS 10T CE-IVD KIT COBAS 4800 HCV GT CTLS 10T CE-IVD KIT COBAS 6800/8800 HEV 96T CE-IVD KIT COBAS 6800/8800 DPX RMC CE-IVD KIT COBAS 6800/8800 HEV RMC CE-IVD HybClear Solution-US EXPORT KIT COBAS 6800/8800 DPX 96T CE-IVD KIT COBAS 4800 LYSIS 2 240T CE-IVD KIT C4800 HCV GT AMP/DET 120T CE-IVD KIT COBAS 58/68/8800 DPX 192T CE-IVD KIT COBAS 58/68/8800 HEV RMC CE-IVD KIT COBAS 4800 SAMPLE PREP 2 240T CE-IVD KIT COBAS 4800 SPEC DIL 2 240T CE-IVD KIT COBAS 58/68/8800 DPX RMC CE-IVD KIT COBAS 4800 HCV 120T CE-IVD KIT COBAS 58/68/8800 HEV 192T CD-IVD Reticulum II Staining Kit VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Pr KAPPA POSITIVE SPECIMEN SLIDES LAMBDA POS SPECIMEN SLIDES VENTANA HE 600 Eosin Red Counterstain II iScan Coreo Scanner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IAC Van Gieson'S Stain Hematology Class 1 864.1850 2021-11-12
KIR Cells, Animal And Human, Cultured Hematology Class 1 864.2280 2016-11-15
MVC System, Test, Her-2/Neu, Ihc Unknown Class 3 N/A 2016-11-10
NKF Immunohistochemistry Antibody Assay, C-Kit Hematology Class 3 864.1860 2016-11-10
JTS Stains, Microbiologic Hematology Class 1 864.1850 2016-11-14
HYF Giemsa Stain Hematology Class 1 864.1850 2016-11-16
NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown Class 3 N/A 2016-11-11
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2018-01-10
PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown Class 3 N/A 2016-11-11
IDA Alcian Blue Hematology Class 1 864.1850 2016-11-16
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor Hematology Class 2 864.1860 2016-11-11
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2000-02-04
GGH Iron Stains Hematology Class 1 864.1850 2016-11-16
ICL Carbol Fuchsin Hematology Class 1 864.1850 2016-11-16
SDP Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit Hematology Class 2 864.1861 2024-12-11
ICH Congo Red Hematology Class 1 864.1850 2016-11-16
HZR Resorcin Fuchsin Hematology Class 1 864.1850 2016-11-16
PRB Cervical Intraepithelial Neoplasia (Cin) Test System Pathology Class 2 864.1865 2019-08-13
KEW Slides, Microscope Pathology Class 1 864.3010 2016-11-14
QUL Immunohistochemistry Assay, Antibody, Folr1 Hematology Class 3 864.1860 2024-10-16
HZT Reagent, Schiff Hematology Class 1 864.1850 2016-11-16
MVC System, Test, Her-2/Neu, Ihc Unknown Class 3 N/A 2023-09-21
PSY Whole Slide Imaging System Pathology Class 2 864.3700 2024-06-28
KES Coverslips, Microscope Slide Pathology Class 1 864.3010 2016-11-11
SHF N/A N/A Class N/A N/A 2026-06-15
HYZ Methenamine Silver Hematology Class 1 864.1850 2016-11-16
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2001-04-23
HYJ Hematoxylin Hematology Class 1 864.1850 2016-11-16
PZJ Lynch Syndrome Test System Immunology Class 2 864.1866 2017-11-08
PRB Cervical Intraepithelial Neoplasia (Cin) Test System Pathology Class 2 864.1865 2017-03-08
SER Immunohistochemistry Assay, Antibody, Met Hematology Class 3 864.1860 2025-05-15
ICZ Ammoniacal Silver Hydroxide Silver Nitrate Hematology Class 1 864.1850 2016-11-16
MAQ Kit, Dna Detection, Human Papillomavirus Unknown Class 3 N/A 2016-11-11
HYS Light Green Hematology Class 1 864.1850 2016-11-16
IBC Diastase Pathology Class 1 864.4400 2016-11-16
HZC Mucicarmine Hematology Class 1 864.1850 2016-11-16
LED Stains, Chemical Solution Hematology Class 1 864.1850 2024-10-23
PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase Unknown Class 3 N/A 2021-05-18
NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer Unknown Class 3 N/A 2020-07-30
HYI Iodine, Grams Hematology Class 1 864.1850 2026-03-30
QZJ Immunohistochemistry Assay, Antibody, Claudin 18 Hematology Class 3 864.1860 2024-10-21
PPM General Purpose Reagent Pathology Class 1 864.4010 2001-03-06
KFD Aniline Blue Hematology Class 1 864.1850 2024-10-23
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2016-11-10
QNH Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay Hematology Class 3 864.1860 2021-05-04
PPM General Purpose Reagent Pathology Class 1 864.4010 2018-05-04
KKP Solution, Silver Carbonate Hematology Class 1 864.1850 2016-11-16
OWF Immunohistochemical Assay, Helicobacter Pylori Microbiology Class 1 866.3110 2016-11-11
KIR Cells, Animal And Human, Cultured Hematology Class 1 864.2280 2022-09-06
HYB Eosin Y Hematology Class 1 864.1850 2016-11-15
HZF Nuclear Fast Red Hematology Class 1 864.1850 2016-11-16
NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity Hematology Class 2 864.1860 2016-11-01
OEO Automated Digital Image Manual Interpretation Microscope Hematology Class 2 864.1860 2016-11-01
NOT Microscope, Automated, Image Analysis, Operator Intervention Hematology Class 2 864.1860 2016-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Roche Diagnostics Operations Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010900203 Roche Diagnostics S.L. Sant Cugat del Valles Barcelona, ES
3039321686 Roche Lumira Dx Stirling Manor Loan Stirling, GB
3039322300 Roche Lumira Dx Bathgate Bathgate Scotland, GB
3011806823 Roche Diabetes Care GmbH Mannheim Baden-Wurttemberg, DE
3020917535 Roche Diagnostics (Suzhou) Ltd. Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243871 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 5.1 2025-03-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-05 Becton Dickinson & Co. 1
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Z-0014-05 Zymed Laboratories Inc. 2
Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.
Z-0015-05 Zymed Laboratories Inc. 2
Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient.
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2028492. Last updated year: 2026. Please use registration number 2028492 when referencing this establishment in official correspondence.
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