FDA.reportPublic FDA data

First Response™ Pregnancy Early Result Pregnancy Test

Primary DI
00022600901259
Brand
First Response™ Pregnancy Early Result Pregnancy Test
Company
CHURCH & DWIGHT CO., INC.
Model
00022600901259
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00022600901259PrimaryGS10
80022600901255Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00022600901259000226009012590226009012590022600901259
8002260090125580022600901255

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinicalA 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 includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)833-9532Consumer.Relations@churchdwight.com

Regulatory Flags#

DUNS number
001211952
Device count
2
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00022600947325Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009473252016-10-13
00022600947400Trojan™ Premium Latex Condoms Ultra Ribbed Ecstasy™000226009474002016-10-13
00022600980506TROJAN™ NaturaLamb™ Luxury Condoms000226009805062016-10-13
00022600987536TROJAN™ NaturaLamb™ Luxury Condoms000226009875362016-10-13
00022600998440TROJAN™ NaturaLamb™ Luxury Condoms000226009984402016-10-13
00022600000600Trojan All The Feels Variety Pack000226000006002020-06-22
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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00075450847666Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
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