FDA.reportPublic FDA data

ACESO Early Pregnancy Test

Primary DI
00810164510020
Brand
ACESO Early Pregnancy Test
Company
ACESO LABORATORIES INC.
Model
U03ST-UHCG-US
Device description
5T, FDA OTC
Published
2026-03-23
Public version status
New
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
K234152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234152000ACESO Early Pregnancy TestAceso Laboratories, Inc.2024-04-05LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810164510020PrimaryGS10
80810164510026Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810164510020008101645100208101645100200810164510020
8081016451002680810164510026

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
003099455
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810164510013ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510037ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510044ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510051ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510068ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510075Atida Fentanyl Drug of Abuse Test RxU02-FYL-US2026-03-23
00810164510082Atida Fentanyl Drug of Abuse Test U02CW-FYL-US2026-03-23
00810164510105Atida hCG Pregnancy Rapid Combo TestUS02-HCG-US2026-03-23
00810164510730Atida Marijuana (THC) Drug of Abuse Strip Test RxU01CW-THC-US2026-03-23
00810164510747Atida Marijuana (THC) Drug of Abuse Rapid Urine Dip CardU04CW-THC-US2026-03-23
00810164510815Atida Viral Transport Medium (Non-inactivated Type)Q01-VTM-US2026-03-23
00810164510006ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510019ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510026ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510033ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510040ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510057ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510064ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
80810164510071Atida Fentanyl Drug of Abuse Test RxU02-FYL-US2026-03-23
80810164510088Atida Fentanyl Drug of Abuse Test U02CW-FYL-US2026-03-23

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