FDA.reportPublic FDA data

Atida hCG Pregnancy Rapid Combo Test

Primary DI
80810164510101
Brand
Atida hCG Pregnancy Rapid Combo Test
Company
ACESO LABORATORIES INC.
Model
US02-HCG-US
Device description
25T, FDA OTC
Published
2026-03-23
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

Product Codes#

Code, Name table
CodeName
JHIVisual, Pregnancy Hcg, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203272000Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.2022-01-31JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810164510105PrimaryGS10
80810164510101Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810164510105008101645101058101645101050810164510105
8081016451010180810164510101

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

Regulatory Flags#

DUNS number
003099455
Device count
25
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810164510013ACESO Early Pregnancy TestU03ST-UHCG-US2026-03-23
00810164510020ACESO 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936983113793Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)Hangzhou AllTest Biotech Co., Ltd.JHI2026-04-22
06936983113809Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)Hangzhou AllTest Biotech Co., Ltd.JHI2026-04-22
06970640093103INNOVITAInnovita (Tangshan) Biological Technology Co., Ltd.JHI2026-04-15
10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-04-09
00810164510105Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
10673486014006Teco Diagnostics One-Step Pregnancy Dipstick TestTECO DIAGNOSTICSJHI2026-02-12
00816862027723HORMONElife™WONDFO USA CO., LTD.JHI2026-01-15
10850082766007QMedix™Diagnostic Automation, Inc.JHI2025-12-24
00850082766000QMedix™Diagnostic Automation, Inc.JHI2025-12-24
00816862028157HORMONElife™WONDFO USA CO., LTD.JHI2025-12-15
00816862028119HORMONElife™WONDFO USA CO., LTD.JHI2025-12-15
20612479280148McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
20612479280162McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479280134McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479280158McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
20612479279722MckessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
20612479279739McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
10612479279855MckessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
10612479279862McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
00661392055650LSL HEALTHCARELSL Industries, LLCJHI2025-06-06
06952062778165HCG Home Use Pregnancy Test Midstream (Colloidal Gold)ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDJHI2025-02-12
56952062778160HCG Home Use Pregnancy Test Midstream (Colloidal Gold)ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDJHI2025-02-12
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-12-19
00850054026651QMedix™Diagnostic Automation, Inc.JHI2024-06-25
20197344024992MedlineMEDLINE INDUSTRIES, INC.JHI2024-03-11
10197344024995MedlineMEDLINE INDUSTRIES, INC.JHI2024-03-11
10673486002409Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-01-16
10673486002379TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TESTTECO DIAGNOSTICSJHI2023-10-26
00816862023787PreviewWONDFO USA CO., LTD.JHI2023-08-03
00816862023800WondfoWONDFO USA CO., LTD.JHI2023-08-03