FDA Registration Active 🇨🇳 China

Roche Diagnostics (Suzhou) Ltd.

Reg #: 3020917535 · FEI: 3020917535 · Expires 2026
Products
3
Proprietary Names
301
Establishment Types
1
Classifications
3

Registration Details

Registration Name
Roche Diagnostics (Suzhou) Ltd.
Registration Number
3020917535
FEI Number
3020917535
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No.259 Zhongyuan Road
City
Suzhou Jiangsu
Country
CN

Regulatory Submissions

510(k) Number
K190773

Owner / Operator

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

US Agent

Business Name
Roche Diagnostics Operations Inc
Contact Name
Brian Frazier
Address
9115 Hague Rd
City
Indianapolis
State
IN
ZIP
46256
Country
US
Phone
317 5214603

Products

Device Name Product Code
Radioimmunoassay, Thyroid-Stimulating Hormone JLW
General Purpose Reagent PPM
Hexokinase, Glucose CFR

Proprietary Names

Elecsys TSH TSH Elecsys E2G 300 V2 TSH Elecsys cobas e 200 V2 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) GLUC HK Gen.3, 800Tests, cobas c, Int. cobas INTEGRA GLUCOSE HK GEN 3 GLUC HK Gen.3, 2200Tests, cobas c701 Glucose HK Gen. 3 COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM

Establishment Types

Manufacture Medical Device