MEIJER OVULATION TEST - EASY ONE STEP

GUDID 00760236169192

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

MEIJER, INC.

Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00760236169192
• NIH Device Record Key: 0cb7c7da-c207-4a14-85be-5532849e7a1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEIJER OVULATION TEST - EASY ONE STEP
• Version Model Number: 16919
• Company DUNS: 006959555
• Company Name: MEIJER, INC.
• Device Count: 7
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 83 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 83 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00674033090323 [Unit of Use]
GS1	00760236169192 [Primary]
GS1	10760236136191 [Package]; Package: Shipping Case [24 Units]; In Commercial Distribution

FDA Product Code

• CEP: Radioimmunoassay, Luteinizing Hormone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-18
• Device Publish Date: 2016-07-22

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