Catalog Number

09005773160

Brand Name

Elecsys Beta-CrossLaps/serum

Version/Model Number

09005773160

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

-

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

86bde120-cf2a-4d2f-abca-b8ed692d62fd

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

October 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-