HealthyWiser LLC

GUDID B469HWLH50HCG503

HEALTHYWISER LLC

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: B469HWLH50HCG503
• NIH Device Record Key: da01399d-adfa-4bda-b2cb-f795ed8265c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthyWiser LLC
• Version Model Number: LH50HCG50
• Company DUNS: 080429253
• Company Name: HEALTHYWISER LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B469HWLH50HCG503 [Primary]
HIBCC	B469HWLHHCG1003 [Unit of Use]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-19