Catalog Number

URS-1B-100G

Brand Name

TECO DIAGNOSTICS

Version/Model Number

URS-1B-100 GENERIC

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

K023297

Product Code

JIO

Product Code Name

Blood, Occult, Colorimetric, In Urine

Public Device Record Key

4bcc4331-0b2b-4e68-b854-0ac0f64a1940

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-