FDA.reportPublic FDA data

First Response Comfort Check Pregnancy Test Kit

Primary DI
00022600999645
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K921099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123436000FIRST RESPONSE EARLY RESULT PREGNANCY TESTChurch & Dwight Co., Inc.2013-08-26LCX
K921099000SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TESTSyntron Bioresearch, Inc.1992-05-29LCX

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 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.

Regulatory Flags#

DUNS number
001211952
Device count
8
Kit
true
Lot or batch
true
Expiration date on label
true

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00022600999492Trojan Variety Pack000226009994922020-07-15
00726893113985Trojan Ultra Thin Condoms007268931139852020-07-07
00726893113992Trojan Ultra Thin Condom007268931139922020-07-16
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00726893800014Trojan Ultra Thin Condom007268938000142020-09-28
00726893800021Trojan Ultra Ribbed Condom007268938000212020-09-28
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Primary DI, Brand, Company table
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