First Response Comfort Check Pregnancy Test Kit

GUDID 80022600999641

Pregnancy Tests for the Detection of Human Chorionic Gonadotropin (hcG) Hormone

CHURCH & DWIGHT CO., INC.

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

• Primary Device ID: 80022600999641
• NIH Device Record Key: 026ede86-73b2-4181-a335-f021f3c780d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Response Comfort Check Pregnancy Test Kit
• Version Model Number: 00022600999645
• Company DUNS: 001211952
• Company Name: CHURCH & DWIGHT CO., INC.
• Device Count: 8
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00022600999645 [Primary]
GS1	80022600999641 [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: 2021-05-11
• Device Publish Date: 2021-05-03

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