MEIJER OVULATION TEST - EASY ONE STEP

Basic Information

• Brand Name: MEIJER OVULATION TEST - EASY ONE STEP
• Primary DI: 00760236169192
• Version / Model: 16919
• Company Name: MEIJER, INC.
• Labeler DUNS: 006959555
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 7
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 4
• Public Version Date: 2018-07-18
• Public Version Status: Update
• Public Device Record Key: 0cb7c7da-c207-4a14-85be-5532849e7a1e

Device Description

One-step ovulation predictor test used for the detection of Luteininzing Hormone (LH) in urine to predict your time of ovulation.

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
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	862.1485	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54254	Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00760236169192	GS1
Unit of Use	00674033090323	GS1
Package	10760236136191	GS1	Shipping Case	24	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 83 Degrees Fahrenheit