FDA.reportPublic FDA data

First Response™ Pregnancy Early Result

Primary DI
80022600901255
Brand
First Response™ Pregnancy Early Result
Company
CHURCH & DWIGHT CO., INC.
Model
00022600001317
Device description
Pregnancy Kit
Published
2023-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00022600001317PrimaryGS10
00022600978633PrimaryGS10
80022600901255Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00022600001317000226000013170226000013170022600001317
00022600978633000226009786330226009786330022600978633
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
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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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00022600999492Trojan Variety Pack000226009994922020-07-15
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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
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Primary DI, Brand, Company table
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