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Teco Diagnostics

FDA UDI

Class II (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name
TECO DIAGNOSTICS FDA UDI
Generic Name
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
URS-2K-100 FINISHED KIT FDA UDI
Model / Reference
URS-2K-100 FDA UDI
Description
URS-2K-100 FINISHED KIT FDA UDI

Identifiers

Catalog Number
URS-2K-100 FDA UDI
Primary DI / UDI-DI
10673486000214 FDA UDI
510(k) Number
K955438 FDA UDI
FDA Product Code
JIL FDA UDI
JIN FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1340 FDA UDI
862.1435 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: Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Teco Diagnostics by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K955438 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA UDI d2e70dfc-661f-4577-83df-aa388180ec3e 36 fields · synced May 30, 2026