ACCU NEWS Ovulation Test + Pregnancy Test Combo

Basic Information

• Brand Name: ACCU NEWS Ovulation Test + Pregnancy Test Combo
• Primary DI: 00850042559017
• Version / Model: strip
• Company Name: CORETESTS, INC.
• Labeler DUNS: 036440919
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: e22f3d58-3881-4027-a247-6b050e8bb870

Device Description

70 pcs/box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33819	Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.	No	Active
65947	Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment as an ovulation signal to optimise the chances of natural conception.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850042559014	GS1		70	In Commercial Distribution
Primary	00850042559017	GS1

Premarket Submissions

Submission Number	Supplement Number
K150063	000