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Teco Diagnostics

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name
TECO DIAGNOSTICS FDA UDI
Generic Name
Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
URS-1K-100 GENERIC FINISHED KIT FDA UDI
Model / Reference
URS-1K-100 GENERIC FDA UDI
Description
URS-1K-100 GENERIC FINISHED KIT FDA UDI

Identifiers

Catalog Number
URS-1K-100G FDA UDI
Primary DI / UDI-DI
10673486000207 FDA UDI
510(k) Number
K003987 FDA UDI
FDA Product Code
JIN FDA UDI
GMDN Term
Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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

No

FDA UDI

Over-the-Counter

Yes

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: Urine ketone IVD, kit, rapid colorimetric, clinical

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

Similar devices

Also classified as Urine ketone IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K003987 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 e82381e8-cd58-4da0-aae3-0ced519ec716 36 fields · synced May 30, 2026