BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    RR Donnelley Global Turnkey Solutions

    Reg #: 3013160357 · FEI: 3013160357 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    36
    Establishment Types
    2
    Classifications
    23

    Registration Details

    Registration Name
    RR Donnelley Global Turnkey Solutions
    Registration Number
    3013160357
    FEI Number
    3013160357
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Blvd Internacional 881, San Jeronimo, CD
    City
    Juarez Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K981271

    Owner / Operator

    Firm Name
    RR Donnelley Global Turnkey Solutions
    Operator Number
    10052247
    Address
    6315 W BY NORTHWEST BLVD
    City
    Houston
    State
    TX
    Postal Code
    77040
    Country
    US
    Correspondent
    Lee Rush

    US Agent

    Business Name
    RR Donnelley
    Contact Name
    Lee Rush
    Address
    6315 North by Northwest Blvd., Houston
    City
    Houston
    State
    TX
    ZIP
    77040
    Country
    US
    Email
    [email protected]
    Phone
    979 4841734

    Products

    Device Name Product Code
    Radioimmunoassay, Luteinizing Hormone CEP
    Covid-19 Test Home Collection Kit Devices QLW
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Discs, Strips And Reagents, Microorganism Differentiation JTO
    Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay SEP
    Stains, Microbiologic JTS
    Needle, Hypodermic, Single Lumen FMI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Coronavirus Antigen Detection Test System. QKP
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Device, Gas Generating KZJ
    Catheter, Irrigation GBX
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Device, Specimen Collection LIO
    Over-The-Counter Covid-19 Antigen Test QYT
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Visual, Pregnancy Hcg, Prescription Use JHI
    Micro Pipette JRC
    Acridine Orange IDC
    Glucose Oxidase, Glucose CGA
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD

    Proprietary Names

    Clearblue Easy Ovulation Kit PrivaPath Diagnostics Ltd Dropper reagents - 10% KOH, 10% Na Desosycholate, Catalase, DMACA Indole, FeCI(3), Indole, Methylene Blue Loeffler, Ninhydrin, Nitrate A and B, Oxidase, PRY, Voges Proskauer A and B Onclarity(TM) Self-Collection Kit Droppers Unifine pentips Clearblue Digital Pregnancy Test Quidel Corporation Bio Bag Clay Adams Ascensia Diabetes Care Clearblue Rapid & Digital Pregnancy Tests Clearblue Flip & Click Pregnancy Test Clearblue Rapid Detection Pregnancy Test Clearblue Early Detection Pregnancy Test Clearblue Triple Assurance Pregnancy Tests Clearblue Early & Digital Pregnancy Tests Affirm™ VPIII Ambient Temperature Transfer System QuickVue COVID-19 test CVS Health at home COVID-19 Test Kit Walgreens At-Home COVID-19 Test Kit Clearblue Digital Ovulation Test Clearblue & Natural Cycles° Birth Control Kit Starter Pack Clearblue Advanced Digital Ovulation Test Clearblue Trying for a Baby Advanced Ovulation Kit Clearblue & Natural Cycles° Birth Control Ovulation Test Refill Pack Clearblue Advanced Digital Ovulation Test Kit Clearblue Trying for a Baby Ovulation Kit Roche Clearblue Fertility Monitor Clearblue Fertility Monitor Test Sticks Accu-Clear Pregnancy Test Clearblue Early Digital Pregnancy Test Livongo Health Inc. Clearblue Smart Ovulation Test

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)