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Teco Diagnostics One-Step Pregnancy Dipstick Test

FDA UDI

Class II (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name
TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TEST FDA UDI
Generic Name
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical FDA UDI
Device Name
The Teco Diagnostics One-Step Pregnancy Dipstick Test is used for the rapid determination of human chorionic gonadotropin (hCG) in human urine to obtain a visual qualitative result for the early detection of pregnancy. FDA UDI
Model / Reference
P595-100 FDA UDI
Description
The Teco Diagnostics One-Step Pregnancy Dipstick Test is used for the rapid determination of human chorionic gonadotropin (hCG) in human urine to obtain a visual qualitative result for the early detection of pregnancy. FDA UDI

Identifiers

Catalog Number
P595-100 FDA UDI
Primary DI / UDI-DI
10673486002379 FDA UDI
510(k) Number
K964536 FDA UDI
FDA Product Code
JHI FDA UDI
GMDN Term
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1155 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical

Teco Diagnostics One-Step Pregnancy Dipstick Test by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA UDI 53a83749-49a2-46e8-ada2-2f1e8f00d514 37 fields · synced Jun 1, 2026