AMPLIM

GUDID 00810477026416

AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)

AMPLIM, LLC

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

• Primary Device ID: 00810477026416
• NIH Device Record Key: 8f6e7656-6b2f-4f95-abbf-c064c26e5bc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPLIM
• Version Model Number: A8177W-20+5
• 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	00810477026416 [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]

• 00810477025501: XA201
• 00810477025587: XA208
• 00810477025570: XA207
• 00810477025563: XA206
• 00810477025556: XA205
• 00810477025532: XA204
• 00810477025525: XA203
• 00810477025518: XA202
• 00810477026232: A8175-15-DV
• 00810477026225: A8173-10-DV
• 00810477026218: A8172-6-DV
• 00810477026201: A8171-3-DV
• 00810477026416: AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
• 00810477026409: AMPLIM Ovulation Test Kit (10 Ovulation Test+ 3 Early Pregnancy Tests)
• 00810477026393: AMPLIM Ovulation Test Kit (5 Ovulation Test+ 2 Early Pregnancy Tests)
• 00810477026379: AMPLIM Ovulation Test Kit (5 Ovulation Test+ 2 Early Pregnancy Tests)
• 00810477026300: AMPLIM Ovulation Test Kit (30 Ovulation Test+ 7 Early Pregnancy Tests)
• 00810477026287: AMPLIM Ovulation Test Kit (20 Ovulation Test+ 5 Early Pregnancy Tests)
• 00810477026270: AMPLIM Ovulation Test Kit (10 Ovulation Test+ 3 Early Pregnancy Tests)