Pregmate Pregnancy Test Strips (50 Count)

Basic Information

• Brand Name: Pregmate Pregnancy Test Strips (50 Count)
• Primary DI: 00850009763075
• Version / Model: 50HCG
• Company Name: Pregmate LLC
• Labeler DUNS: 071197287
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-08-16
• Public Version: 1
• Public Version Date: 2023-08-24
• Public Version Status: New
• Public Device Record Key: 78054601-54ef-4a39-bf45-ba5a02565e9a

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: No
• 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: No
• 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
54210	Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or 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 using an enzyme immunoassay (EIA) method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850009763259	GS1
Primary	00850009763075	GS1

Premarket Submissions

Submission Number	Supplement Number
K213808	000