First Response Comfort Check Pregnancy Test Kit

GUDID 80022600999641

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

CHURCH & DWIGHT CO., INC.

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Primary Device ID80022600999641
NIH Device Record Key026ede86-73b2-4181-a335-f021f3c780d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirst Response Comfort Check Pregnancy Test Kit
Version Model Number00022600999645
Company DUNS001211952
Company NameCHURCH & DWIGHT CO., INC.
Device Count8
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100022600999645 [Primary]
GS180022600999641 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-11
Device Publish Date2021-05-03

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