Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013160357

FEI Number

3013160357

Entity Name

RR Donnelley Global Turnkey Solutions

City/State/Country

Juarez Chihuahua, MX

Establishment Address

Blvd Internacional 881, San Jeronimo, CD, Juarez Chihuahua MX, MX

Establishment Type(s)

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

Owner / Operator

RR Donnelley Global Turnkey Solutions (Owner Number: 10052247)

Owner / Operator Contact Address

6315 W BY NORTHWEST BLVD, Houston, TX 77040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 PrivaPath Diagnostics Ltd 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 Clearblue Early Detection Pregnancy Test Roche Clearblue Fertility Monitor Clearblue Fertility Monitor Test Sticks Accu-Clear Pregnancy Test Clearblue Early Digital Pregnancy Test Clearblue Triple Assurance Pregnancy Tests Clearblue Early & Digital Pregnancy Tests Droppers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2022-07-07
QLW	Covid-19 Test Home Collection Kit Devices	Unknown	Class N	N/A	2020-09-07
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2023-05-31
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2018-07-19
SEP	Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay	Microbiology	Class 2	866.2920	2026-04-16
JTS	Stains, Microbiologic	Hematology	Class 1	864.1850	2018-07-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-06-09
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-07-07
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-05-17
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-06-26
KZJ	Device, Gas Generating	Microbiology	Class 1	866.2580	2018-07-19
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2018-07-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2021-03-08
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2021-03-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2021-03-08
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-07-07
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2024-07-31
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2018-07-11
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2024-10-31
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2024-07-31
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-07-07
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2022-07-07
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2022-09-22
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2022-07-07
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-07-07
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-07-07
IDC	Acridine Orange	Hematology	Class 1	864.1850	2018-07-19

Official Correspondent

Lee Rush

US Agent Details

Lee Rush Business: RR Donnelley Email: lee.m.rush@rrd.com Phone: (979) 4841734

Related Public Records

Same Entity

RR Donnelley Global Turnkey Solutions

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-05	Becton Dickinson & Co.	1	Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013160357. Last updated year: 2026. Please use registration number 3013160357 when referencing this establishment in official correspondence.