FDA.reportPublic FDA data

First Response Comfort Check Pregnancy Test Kit

Primary DI
80022600999641
Brand
First Response Comfort Check Pregnancy Test Kit
Company
CHURCH & DWIGHT CO., INC.
Model
00022600999645
Device description
Pregnancy Tests for the Detection of Human Chorionic Gonadotropin (hcG) Hormone
Published
2021-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123436000FIRST RESPONSE EARLY RESULT PREGNANCY TESTChurch & Dwight Co., Inc.2013-08-26LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00022600999645PrimaryGS10
80022600999641Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00022600999645000226009996450226009996450022600999645
8002260099964180022600999641

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001211952
Device count
8
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DI, Brand, Model table
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00022600000709Trojan All The Feels Variety Pack000226000007092020-07-29
00022600300007Trojan All the Feels Condom000226003000072020-06-10
00022600999492Trojan Variety Pack000226009994922020-07-15
00726893113985Trojan Ultra Thin Condoms007268931139852020-07-07
00726893113992Trojan Ultra Thin Condom007268931139922020-07-16
00726893114005Trojan Ultra Thin Condom007268931140052020-07-08
00726893114043Trojan Magnum007268931140432020-03-12
00726893114098Trojan Magnum Condom007268931140982020-03-27
00726893114104Trojan Enz007268931141042020-03-20
00726893800014Trojan Ultra Thin Condom007268938000142020-09-28
00726893800021Trojan Ultra Ribbed Condom007268938000212020-09-28
00726893800038Trojan Mangum Condom007268938000382020-09-28
00022600019831TROJAN 100CT BULK MIX000226000198312018-10-30

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Primary DI, Brand, Company table
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06938444982801DAVIDEquinox Biotech Co., Ltd.LCX2026-06-01
00049696240482VeriQuickFOURSTAR GROUP INC.LCX2026-04-13
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00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
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