Catalog Number

URS-10-100T

Brand Name

TECO DIAGNOSTICS

Version/Model Number

URS-10-100 TC-THUNDERBOLT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141289

Product Code

CDM

Product Code Name

Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Public Device Record Key

5cd3c2b0-3099-40c0-a589-d6ac76bbfdb5

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

May 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-