FDA.reportPublic FDA data

Best Choice One Step Pregnancy Test

Primary DI
00070038607434
Brand
Best Choice One Step Pregnancy Test
Company
VALU MERCHANDISERS COMPANY
Model
FPPL
Device description
FPPL Best Choice DPS +/-
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K042280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042280000FACT PLUS ONE-STEP PREGNANCY TEST KITUnipath , Ltd.2004-09-10LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10070038607431PackageGS124In Commercial Distribution
10070038621185PackageGS16In Commercial Distribution
00070038607434PrimaryGS10
00633472000133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007003860743110070038607431
1007003862118510070038621185
00070038607434000700386074340700386074340070038607434
00633472000133006334720001336334720001330633472000133

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-899-7353xx@xx.xx

Regulatory Flags#

DUNS number
868703513
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070038662396Best Choice One Step Pregnancy Test2021-04-16
00070038662402Best Choice One Step Pregnancy Test2021-04-16
00070038581369Best Choice One Step Pregnancy TestFPPL2016-06-30
00070038650539Best Choice Early Result Pregnancy TestPLPL2016-06-30
00070038627852Best Choice7259787259782022-06-16
10070038627859Best Choice7259787259782022-06-16
00070038202714Best Choice TamponsBAWAR402016-09-20
00070038202721Best Choice TamponsBAWAS402016-09-20
00070038202974Best ChoiceBUSBCSDMXR242020-06-01
00070038203308Best Choice TamponsBAWAP402016-09-20
00070038203315Best Choice TamponsBAWAR102016-09-20
00070038203322Best Choice TamponsBAWAS102016-09-20
00070038596028Best Choice TamponsBAWAC402016-09-20
00070038610618Best Choice TamponsBAWGR202016-09-20
00070038610632Best Choice TamponsBAWGS182016-09-20
00070038622666Best Choice TamponsBAWGC362016-09-20
00070038651390Best Choice TamponsBAWUS182016-09-20
00070038651406Best Choice TamponsBAWUR182016-09-20
10070038202971Best ChoiceBUSBCSDMXR242020-06-01
10070038662393Best Choice One Step Pregnancy Test2021-04-16

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Primary DI, Brand, Company table
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06950996030694Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
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