AMPLIM Ovulation Test Kit

GUDID 00810477026386

AMPLIM Ovulation Test Kit (5 Ovulation Test+ 2 Early Pregnancy Tests + 1 Digital Basal Thermometer)

AMPLIM, LLC

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810477026386
• NIH Device Record Key: 360e2004-515a-491d-bd0a-605dd81eb89e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPLIM Ovulation Test Kit
• Version Model Number: A8179W-5+2+T
• Company DUNS: 080521945
• Company Name: AMPLIM, LLC
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810477026386 [Primary]

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

On-Brand Devices [AMPLIM Ovulation Test Kit]

• 00810477026386: AMPLIM Ovulation Test Kit (5 Ovulation Test+ 2 Early Pregnancy Tests + 1 Digital Basal Thermomet
• 00810477026362: AMPLIM Ovulation Test Kit (5 Ovulation Test+ 2 Early Pregnancy Tests + 1 Digital Basal Thermomet