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

FDA UDIFDA 510(k)

Class II (US FDA UDI)

510(k) K936031

by Teco Diagnostics

Identity

Trade Name
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card Test FDA UDI
Generic Name
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card 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. FDA UDI
Model / Reference
P596-25 FDA UDI
Description
Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card 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. FDA UDI

Identifiers

Catalog Number
P596-25 FDA UDI
Primary DI / UDI-DI
10673486002454 FDA UDI
510(k) Number
K964461 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 Urine/Serum Combo Pregnancy Card Test by Teco Diagnostics — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k)

Similar devices

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

Cleared under the same submission

K964461 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Teco Diagnostics

Sources (2)

  • FDA UDI 080c6d11-7217-4a11-aa98-06b910d9cd68 61 fields · synced Jun 18, 2026
  • FDA 510(k) K936031 1 fields · synced Jun 4, 2026