Pregmate Pregnancy Test Strips (50 Count)

GUDID 00850009763167

Pregmate LLC

Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850009763167
• NIH Device Record Key: 97d3aada-baa3-4f74-b492-b4a54366ae4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pregmate Pregnancy Test Strips (50 Count)
• Version Model Number: 50HCG
• Company DUNS: 071197287
• Company Name: Pregmate LLC
• Device Count: 50
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850009763167 [Primary]
GS1	00850009763259 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213808

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: 2023-04-11
• Device Publish Date: 2023-04-03

On-Brand Devices [Pregmate Pregnancy Test Strips (50 Count)]

• 00850009763167: 50HCG
• 00850009763259: 100HCG