FDA.report

Walgreens

Primary DI
10311917083800
Brand
Walgreens
Company
WALGREEN CO.
Model
620731
Catalog number
N/A
Device description
Walgreens Advanced One Step Pregnancy Test with FloodGuard Technology, 2 count
Published
2026-02-17
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

Related Records

Product Codes

CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Premarket Submissions

SubmissionSupplement
K042280000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10311917083800PackageGS124In Commercial Distribution
00311917083803PrimaryGS10
00633472000492Unit of UseGS10

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-899-7353consumerrelations.pq@walgreens.com

Regulatory Flags

DUNS number
008965063
Device count
2
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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