Answer™ Ovulation Test Daily Tracker

GUDID 00022600407089

CHURCH & DWIGHT CO., INC.

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

• Primary Device ID: 00022600407089
• NIH Device Record Key: 88948c33-ae85-4f56-8320-006d8e082049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Answer™ Ovulation Test Daily Tracker
• Version Model Number: 00022600407089
• Company DUNS: 001211952
• Company Name: CHURCH & DWIGHT CO., INC.
• Device Count: 20
• DM Exempt: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00022600407089 [Primary]
GS1	80022600407085 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973310

FDA Product Code

• CEP: RADIOIMMUNOASSAY, LUTEINIZING HORMONE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-10-14

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