← Back to catalogue

Teco Diagnostics

FDA UDI

Class I (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-9-100 FINISHED KIT FDA UDI
Model / Reference
URS-9-100 FDA UDI
Description
URS-9-100 FINISHED KIT FDA UDI

Identifiers

Catalog Number
URS-9-100 FDA UDI
Primary DI / UDI-DI
10673486000382 FDA UDI
510(k) Number
K954977 FDA UDI
FDA Product Code
JMT FDA UDI
CDM FDA UDI
JIR FDA UDI
CEN FDA UDI
JIO FDA UDI
JRE FDA UDI
JIN FDA UDI
JJB FDA UDI
JIL FDA UDI
GMDN Term
Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1510 FDA UDI
862.1785 FDA UDI
862.1645 FDA UDI
862.1550 FDA UDI
864.6550 FDA UDI
862.2800 FDA UDI
862.1435 FDA UDI
862.1115 FDA UDI
862.1340 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 I — 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

K954977 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA UDI 4049feb2-4509-49da-a803-4abcf1ba524a 36 fields · synced May 31, 2026