Catalog Number

-

Brand Name

Urine CartiLaps ® (CTX-II) EIA

Version/Model Number

AC-10F1

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

-

Product Code

JMM

Product Code Name

Column Chromatography & Color Development, Hydroxyproline

Public Device Record Key

4b90181f-f323-4ec7-b16b-6fee80891e78

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-