ELATE

GUDID 00810477026676

E-HCG-Pregnancy Test Strip-100W

AMPLIM, LLC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810477026676
• NIH Device Record Key: 15654f4f-acb1-4278-b487-64b0a95b8276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELATE
• Version Model Number: E-HCG-Pregnancy Test Strip-100W
• 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: false
• 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	00810477026676 [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: 2025-03-10
• Device Publish Date: 2025-02-28

On-Brand Devices [ELATE]

• 00810477026676: E-HCG-Pregnancy Test Strip-100W
• 00810477026669: E-HCG-Pregnancy Test Strip-100A
• 00810477026652: E-HCG-Pregnancy Test Strip-60W
• 00810477026638: E-HCG-Pregnancy Test Strip-60A
• 00810477026621: E-HCG-Pregnancy Test Strip-30W
• 00810477026607: E-HCG-Pregnancy Test Strip-30A