Catalog Number

8892382

Brand Name

VITROS

Version/Model Number

8892382

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

K980283

Product Code

KLT

Product Code Name

ENZYME IMMUNOASSAY, CARBAMAZEPINE

Public Device Record Key

48c41a63-eb65-461e-9520-b9a96e151f28

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-