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
- [email protected]
- Phone
- 317 5214603
Products
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