FDA.reportPublic FDA data

Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test

Primary DI
10673486014020
Brand
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test
Company
TECO DIAGNOSTICS
Model
P597-25
Catalog number
P597-25
Device description
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick Test is a colloidal gold antibody complex based immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy.
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K964462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964462000ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TESTTeco Diagnostics1997-02-11JHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486014020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348601402010673486014020

GMDN Terms#

Term, Definition table
TermDefinition
Human chorionic gonadotropin beta-subunit 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 the beta subunit on the intact HCG hormone and/or free beta subunit (beta-HCG) 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 for early detection of pregnancy, as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage), or as an indicator of trisomy 21 (Down syndrome) during pregnancy. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
7144631111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00810164510105Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
80810164510101Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
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