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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: A1CD, cobas c 503; Accelerator I 1 x 100ML; Acid Wash Solution; Acid wash Solution 2x1,8 L; Acid wash Solution 2x2 L; Activator for cobas c,Integra,c111; Alu Positive Control Probe II; Antibody Dilution Buffer; Antigen Excess Reagent; BASIC WASH 2x2 L; Benchmark Special Stains Cleaning Kit; BenchMark Special Stains Deparaffinization Solution (10X); BenchMark Special Stains Liquid Coverslip; BlankCell Elecsys,cobas e; Cell Check Elecsys,cobas e; Cell Wash Solution I/NaOH-D 2x1.9L; Clean Cell M 2x2L Elecsys, cobas e; CleanCell Elecsys,cobas e; CleanCell M 2x2 L Elecsys,cobas e; Cleaner Basisch cobas c111; CLEANING KIT for CL- ELECTRODE; CLEANING SOLUTION 988-4 (125 ML); CLEANING SOLUTION FOR AVL COMPACT II; cobas c 70X Internal Standard/2000 mL; cobas c 70x KCL/500 mL; cobas C SPECIAL CELL CLEANING SOLUTION; cobas Integra Cleaner; cobas Integra Cleaner 150Tests; cobas Integra FP Sample Dilution; COBAS INTEGRA ISE ETCHER 6 x 11ML; cobas Integra NACl Diluent 9 %; cobas omni Utility Channel (192T); cobas® PCR Media; cobas® Sample Prep Buffer; cobas® Sample Prep Buffer (CSPB); cobas® Specimen Pre-Extraction Reagent; cobas® Specimen Pre-Extraction Reagent (SPER); dATP,PCR Grade Di-Na solution; dATP,PCR Grade Di-Na Solution 4x125 uM; dCTP,PCR Grade Di-Na slt; dCTP,PCR Grade Di-Na solution; dCTP,PCR Grade Di-Na Solution 4x125 uM; DEPROTEINIZER (125 ML); dGTP, PCR Grade; Digital LightCycler® DNA Master Kit; Digital LightCycler® Partitioning Fluid; Digital LightCycler® RNA Master Kit; Diluent MultiAssay E2G; Diluent MultiAssay Elecsys,cobas e; Diluent Universal E2G; DNA AWAY; dTTP, PCR Grade, 125 umol; dTTP, PCR Grade, 25 umol; dTTP,PCR Grade Di-Na Solution 4x125 uM; dUTP, PCR Grade, 25 umol; dUTP,PCR Grade Di-Na Solution 4x125 uM; ECL-LC, BV-CLEAN Plus, 1000ml; ECL-LC, BV-DILUENT, 250ml; ECL-LC, BV-GLO Plus, 1000ml; ECL-LC, BV-SANITIZE, 100ml; ECL-LC, BV-STORE, 250ml; Eco Detergent; EcoTergent; EcoTergent, cobas c503; ELECSYS SAP BUFFER; Elecsys SYSCLEAN; EZ Prep Concentrate (10X); FLUID PACK S2 (1 PC); GC-RICH PCR System 2.2 KU; Hemolyzing reagent; Hemolyzing reagent f.TQ HBA1c,cobas c513; High Pure PCR Template Preparation Kit; High Pure Viral NA Large Volume Kit; High Pure Viral RNA Kit; High PureViral Nucleic Acid Kit; HITACHI ISE 1N KCL ELECT SOLUTION 1L; Hitergent c311; Hitergent cobas c701; HP PCR Template Preparation Kit; HP Viral Nucleic Acid Buffer Set; HP Viral Nucleic Acid Kit; HP Viral RNA Kit; HybReady Solution; Hybridization Wash Buffer Kit; HypoCleaner; Ionify AxisSol cobas i 1x500ml; Ionify Deproteinizer (iDEPRO); Ionify Deproteinizer iDepro (6x21ML); Ionify Derivatization Reagent 1 (iDR1); Ionify Diluent 1 (iDIL1); Ionify iDIL cobas i; Ionify iDR1 cobas i; Ionify iPTReag1 cobas i; Ionify iPTReag2 cobas i; Ionify iPTWB cobas i; Ionify Mass Axis Solution (iAxisSol); Ionify Pretreatment 1 (iPT1); Ionify Pretreatment 2 (iPT2); Ionify Pretreatment Whole Blood (iPTWB); Ionify SysR CS cobas i 1x1L; Ionify SysR S1 cobas i 4x500ml; Ionify SysR S2 cobas i 1x1L; Ionify SysR S3 cobas i 1x1L; Ionify SysR S4 cobas i 1x1L; Ionify SysR VB1 cobas i 4x500ml; Ionify SysR VB2 cobas i 4x500ml; Ionify SysR VB3 cobas i 4x500ml; Ionify SysR VB4 cobas i 1x500ml; Ionify System Reagent CS (iSysR CS); Ionify System Reagent S1 (iSysR S1); Ionify System Reagent S2 (iSysR S2); Ionify System Reagent S3 (iSysR S3); Ionify System Reagent S4 (iSysR S4); Ionify System Reagent VB1 (iSysR V1); Ionify System Reagent VB2 (iSysR V2); Ionify System Reagent VB3 (iSysR V3); Ionify System Reagent VB4 (iSysR V4); ISE DEPROTEINIZER cobas c 111 system; ISE DEPROTEINIZER cobas integra (6x21ML); ISE Diluent Gen.2, 2x2 Liter; ISE Diluent Gen.2, cobas c, Hitachi; ISE ETCHER cobas c 111 system; ISE Int.Stand. Gen.2, cobas c, Hitachi; ISE Reference Electrolyte; ISE Reference Electrolyte 500ML; ISE Reference Electrolyte, 2L; ISH Amplification Kit; ISH Negative Control; ISH Peroxidase Inhibitor; KIT COBAS 58/68/88 UTIL CHAN 192T IVD; KIT COBAS 6800/8800 HEV 96T CE-IVD; KIT COBAS PRIME PCR MEDIA IVD; KIT COBAS PRIME SAMPLE PREP BUFFER IVD; KIT COBAS PRIME SPEC PRE-EXTRACTION IVD; KIT ELECSYS CLEAN-CELL M 2X2 L; LC Capillaries (100 ul); LC CD Manual complete SW 4.1; LC Control Kit DNA; LC Control Kit RNA; LC DNA Master Hy. Pb, 96 react.; LC DNA Master Hy.Pb, 480 react.; LC EBV Rec Template; LC EvoScript RNA Probes Master (200); LC EvoScript RNA SYBR Green Master (200); LC EvoScript RNA SYBR Green Master 1000; LC FastStart Master Hyb Probes, M-Grade; LC FS DNA Master Hy.Pb, 480 react.; LC FS DNA Master Hy.Pb., 96 react.; LC FS DNA Master^PLUS HY-Pb, 96 react.; LC FS DNA Master^PLUS Hy.Pb, 480 react.; LC FS DNA MasterPLUS HP, 100 ul; LC HSV 1/2 Template DNA; LC Multicolor Demo Set; LC Multiplex DNA Master HP; LC Multiplex RNA Virus Master, 1000; LC Multiplex RNA Virus Master, 200; LC QC Kit; LC RNA Amplification Kit, Hyb. Probes; LC RNA Master Hybridization Probes; LC Strep B PTS1 GPR; LC Uracil-DNA Glycosylase; LCS (Predilute); LightCycler Capillaries (20ul) 5x96; LightCycler Capillaries 100ul,M-grade; LightCycler EvoScript RNA Probes Master, 1000 Reactions; LightCycler EvoScript RNA Probes Master, 200 Reactions; LightCycler EvoScript RNA SYBR Green Master 1000; LightCycler EvoScript RNA SYBR Green Master 200; LIGHTCYCLER MULTIPLEX DNA MASTER, 1000 rx; LIGHTCYCLER MULTIPLEX DNA MASTER, 200 rx; M-MLV RT, Mutante 3; MagNA Lyser Green Beads; MagNA Pure 24 MGP set; MagNA Pure 24 Total NA Isolation Kit; MagNa Pure 96 System Fluid; MagNA Pure Compact RNA Isolation Kit; MagNA Pure DNA Tissue Lysis Buffer; MagNA Pure LC tNA Isol. Kit HP; MP Bacteria Lysis Buffer; MPC Nucleic Acid Isol. Kit I Large Vol.; MPC Nucleic Acid Isolation Kit I; MPLC Cartridge Seal; MPLC Disposable; MPLC DNA Isol. Kit I; MPLC DNA Isol. Kit II (Tissue); MPLC DNA Isol. Kit III (Bacteria); MPLC DNA Isol. Kit Large Volume; MPLC DNA Isol.KitI-Lysis/Bind.Buf.Refill; MPLC Greasing Set; MPLC mRNA HS Kit; MPLC mRNA Isol. Kit I - Lysis Buf.Refill; MPLC O-Ring Maintenance Kit; MPLC Processing Cartridges; MPLC Reaction Tip (large); MPLC Reaction Tip (small); MPLC Reagent Tub (medium); MPLC Reagent Tub (small); MPLC RNA Isol. Kit High Performance; MPLC RNA Isol. Kit III Tissue; MPLC RNA Isol.Tissue Lysis Buffer Refill; MPLC Sample Cartridges; MPLC Total NA Isolation Kit-Large Volume; MPLC Total Nucleic Acid Isolation Kit; MPLC totalNA Isol.Kit-Lysis/Bind.Buf.Ref; MPLC Tub Lid (small, medium); MPLC Tub Lid Seal; MPLC Waste Bag; MPLC Waste Bottle; NaCL 9% cobas c 111; NACl 9% Dil, cobas c; NACl 9% Dil, cobas c 701; NACl 9% Dil, cobas c503, 123T; NACl 9% SI Gen.2, 14500Tests, cobas c503; NACl 9% SI Gen.2, 3000Tests cobas c701; NACl 9% SI Gen.2, cobas c, Integra; NaCl or Sodium Chloride; NaOH-D / Basic Wash; NaOH-D or Sodium Chloride Detergent; NaOH-D, 123Tests, cobas c503; NaOH-D, cobas c; NaOH-D, cobas c 701; NaOH-D/Basic Wash 2x1,8 L; NucleoMix, 25mmol/l, 0.6 ml, GPR; OMNI SOLUTION 2 (4x40 ML); PCR Buffer (10x) with MgCl2 GPR; PCR Buffer without MgCl_2 , 10 x; PCR ENZYME, CUSTOM SQNM; PCR Enzyme, custom SQNM 1250 units; PCR-M Elution Buffer 50mM pH 8,1, MBF; Phosphatase,alkaline(AP),MB Grade(1U/ul); Phosphatase,alkaline(AP),MB grd.(20U/ul); PreClean M Elecsys,cobas e; PreClean M G2 2x2L Elecsys E2G; Probe Wash M Elecsys,cobas e; ProCell Elecsys,cobas e; ProCell M 2x2 L Elecsys,cobas e; ProCell M G2 2x2L Elecsys E2G; PYP, 950T, cobas c 503; Pyridoxal phosphate; RealTime ready RNA Virus Master; RINSE ADDITIVE SOLUTION (100x1 ML); RNA Positive Control Probe; S.E.T.S.; S.E.T.S. II Kit; S.T.A.R.; S1 RINSE SOLUTION (2 PCS); S2 FLUID PACK (1 PC); S3 FLUID PACK A (1 PC); Sample Cleaner 1, cobas 8000; Sample Cleaner 1, cobas c; Sample Cleaner 2, cobas 6000; Sample Cleaner 2, cobas 8000; SAP Test Elecsys,cobas e; SARS-CoV-2 Inactivation Solution; SARS-CoV-2 Inactivation Solution UTM/VTM; SCCS, 50Tests, cobas c503; Serum Index Gen.2; SET STREPTAVIDIN PHYCOERYTHRIN 1.0mL LUO; SMS Solution for HIT 917; SMS, cobas c; SMS, cobas c 701; SMS, cobas c503, 123T; SODIUM ELECTRODE CONDITIONER (125 ML); Special Cell Cleaning Solution; Special Cell Cleaning Solution, c513; Special Stains Cleaning Kit; Special Stains Heavy Metal Extraction System; Special Stains Vapor Extraction System; Special Wash Solution; START, 1000T, cobas c 503; Sys Wash Elecsys,cobas e; Terminal Transferase, recomb. (24 000 U); Terminal Transferase,recombinant (8000U); ULTRA LCS (Predilute); ultraView Alkaline Phosphatase Red ISH Detection Kit; ultraView Red ISH DIG Detection Kit; ultraView Silver Wash II; ultraView SISH Detection Kit; ultraView SISH DNP Detection Kit; Universal Diluent 2x36ml Elecsys,cobas e; Uracil-DNA Glycosylase,Heat-labile,100 U; Uracil-DNA Glycosylase,Heat-labile,500 U; URINE DILUENT (500 ML); VENTANA BenchMark Special Stains Wash II; VENTANA HE 600 Bluing; VENTANA HE 600 Cleaning Solution; VENTANA HE 600 Coverslip Activator; VENTANA HE 600 Differentiating Solution; VENTANA HE 600 Organic Solution; VENTANA HE 600 Transfer Fluid; VENTANA HE 600 Wash; VENTANA ISH iVIEWBlue Detection Kit; VENTANA ISH iVIEWBlue Plus Detection Kit
Classification Name: GENERAL PURPOSE REAGENT
Product Code: PPM
Device Class: 1
Regulation Number: 864.4010
Medical Specialty: Pathology
Registered Establishment Name: ROCHE DIAGNOSTICS GMBH
Registered Establishment Number: 9610126
Owner/Operator: Roche Diagnostics Operations Inc.
Owner/Operator Number: 9039767
Establishment Operations: Foreign Exporter; Manufacturer; Repackager/Relabeler; Specification Developer
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