Catalog Number

83-0009-01

Brand Name

EliA APS Positive Control 2500/5000

Version/Model Number

83-0009-01

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

K181329,K181329

Product Code

MID

Product Code Name

SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL

Public Device Record Key

4665147a-0fb6-4a57-9f13-484af2da3883

Public Version Date

December 17, 2020

Public Version Number

1

DI Record Publish Date

December 09, 2020

Package DI Number

07333066014197

Quantity per Package

6

Contains DI Package

07333066013183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-