EZ-hCG Urine Pregnancy Test

Basic Information

• Brand Name: EZ-hCG Urine Pregnancy Test
• Primary DI: 00083059104851
• Version / Model: 1048-25
• Company Name: BIOMERICA, INC.
• Labeler DUNS: 067647321
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-01
• Public Version: 1
• Public Version Date: 2020-07-09
• Public Version Status: New
• Public Device Record Key: a1484803-f555-4f4e-80fb-6de00b71fd42

Device Description

The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54216	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083059104851	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K003856	000