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Data / Medical devices / Mexico / RR Donnelley Global Turnkey Solutions

RR Donnelley Global Turnkey Solutions: FDA-registered device maker in Juarez Chihuahua, Mexico, 9 510(k) clearances

RR Donnelley Global Turnkey Solutions is registered with the FDA (registration 3013160357) in Juarez Chihuahua, Mexico. It lists 23 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch RR Donnelley Global Turnkey Solutions
FDA registration number
3013160357
Address
Blvd Internacional 881 San Jeronimo, CD, Juarez Chihuahua, Mexico, MX
Owner or operator
RR Donnelley Global Turnkey Solutions (10052247)
Roles
Contract manufacturer, Repackager or relabeler
First device listed
July 11, 2018
Registered through
2026
Brand names listed
Accu-Clear Pregnancy Test, Affirm™ VPIII Ambient Temperature Transfer System, Ascensia Diabetes Care, Bio Bag, CVS Health at home COVID-19 Test Kit, Clay Adams, Clearblue & Natural Cycles° Birth Control Kit Starter Pack, Clearblue & Natural Cycles° Birth Control Ovulation Test Refill Pack and more

Devices it lists

DeviceProduct codeClassRoleSource
Acridine OrangeIDC1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Blood Specimen Collection Convenience Kit (Excludes Hiv)PQD2Contract manufactureraccessdata.fda.gov
Catheter, IrrigationGBX1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Coronavirus Antigen Detection Test System.QKPNContract manufactureraccessdata.fda.gov
Covid-19 Test Home Collection Kit DevicesQLWNContract manufactureraccessdata.fda.gov
Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular AssaySEP2Contract manufactureraccessdata.fda.gov
Device, Gas GeneratingKZJ1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Specimen CollectionLIO1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Discs, Strips And Reagents, Microorganism DifferentiationJTO1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Glucose Dehydrogenase, GlucoseLFR2Contract manufactureraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Contract manufactureraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Repackager or relabeleraccessdata.fda.gov
Micro PipetteJRC1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract manufactureraccessdata.fda.gov
Over-The-Counter Covid-19 Antigen TestQYT2Contract manufactureraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNContract manufactureraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Contract manufactureraccessdata.fda.gov
Stains, MicrobiologicJTS1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Contract manufactureraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Repackager or relabeleraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Repackager or relabeleraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 21, 2022K213379Clearblue ® Early Pregnancy TestLCXSubstantially EquivalentSpd Swiss Precision Diagnostics GmbHaccessdata.fda.gov
August 13, 2021K200913Clearblue® Early Digital Pregnancy TestLCXSubstantially EquivalentSpd Swiss Precision Diagnostics GmbHaccessdata.fda.gov
December 22, 2017K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)JHISubstantially EquivalentTrue Diagnostics, Inc.accessdata.fda.gov
May 12, 2011K110433CLEARBLUE EASY PREGNANCY TESTLCXSubstantially EquivalentSPD Development Company Limitedaccessdata.fda.gov
May 25, 2006K060128CLEARBLUE EASY DIGITAL PREGNANCY TESTLCXSubstantially EquivalentUnipath , Ltd.accessdata.fda.gov
September 10, 2004K042280FACT PLUS ONE-STEP PREGNANCY TEST KITLCXSubstantially EquivalentUnipath , Ltd.accessdata.fda.gov
October 28, 1998K981207CLEARPLAN EASY FERTILITY MONITORNGESubstantially EquivalentUnipath , Ltd.accessdata.fda.gov
June 25, 1998K981271CLEARPLAN EASY OVULATION TESTCEPSubstantially EquivalentUnipath , Ltd.accessdata.fda.gov
July 30, 1992K920536AFFIRM VP SAMPLE COLLECTION SETLIOSubstantially EquivalentMicroprobe Corp.accessdata.fda.gov

Compare with other makers

Updated September 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.