Catalog Number

11876317160

Brand Name

Elecsys PreciControl Anti-HBs

Version/Model Number

11876317160

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2019

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

P010054,P010054,P010054,P010054,P010054

Product Code

LOM

Product Code Name

Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Public Device Record Key

d7ec2ea4-c81f-4b38-80a8-4571b52f7d10

Public Version Date

May 31, 2019

Public Version Number

5

DI Record Publish Date

September 10, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-