First Response™ Pregnancy Triple Check Pregnancy Test Kit

GUDID 80022600020208

CHURCH & DWIGHT CO., INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 80022600020208
• NIH Device Record Key: d1eb8735-f78c-4dc6-b7e8-20bae02a4759
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Response™ Pregnancy Triple Check Pregnancy Test Kit
• Version Model Number: 00022600020202
• Company DUNS: 001211952
• Company Name: CHURCH & DWIGHT CO., INC.
• Device Count: 3
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com
• Phone: +1(800)833-9532
• Email: Consumer.Relations@churchdwight.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00022600020202 [Primary]
GS1	80022600020208 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123436

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: 2021-12-14
• Device Publish Date: 2021-12-06

On-Brand Devices [First Response™ Pregnancy Triple Check Pregnancy Test Kit]

• 00061700900700: FR-Early Result, Digital (Gold), Rapid Results
• 80022600020208: 00022600020202