Catalog Number

DECC055330

Brand Name

EliA ß2-Glycoprotein I IgM Well

Version/Model Number

DECC055330

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

K091845,K091845

Product Code

MSV

Product Code Name

System,test,antibodies,b2 - glycoprotein i (b2 - gpi)

Public Device Record Key

5d5c8f30-b96f-4b54-80a4-1db0db5856b6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

07333066010809

Quantity per Package

4

Contains DI Package

07333066014760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-