PREGMATE

GUDID 00850065976648

PREGMATE® Digital Ovulation Test

Guangzhou Decheng Biotechnology Co., LTD

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 00850065976648
• NIH Device Record Key: 91f8953c-ff94-4a07-b0a2-28754e016467
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREGMATE
• Version Model Number: 1T
• Company DUNS: 554534314
• Company Name: Guangzhou Decheng Biotechnology Co., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	00850065976648 [Primary]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), 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: 2024-10-07
• Device Publish Date: 2024-09-27

On-Brand Devices [PREGMATE]

• 00850065976648: PREGMATE® Digital Ovulation Test
• 30850065976632: PREGMATE® OVULATION TEST STRIP
• 30850065976625: PREGMATE® PREGNANCY TEST STRIP