Catalog Number

2500LONG

Brand Name

IMMCO DIAGNOSTICS

Version/Model Number

2500LONG

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

K883915

Product Code

DBL

Product Code Name

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Public Device Record Key

997c3cea-48c6-4589-a5b5-e2ba605722df

Public Version Date

September 24, 2018

Public Version Number

4

DI Record Publish Date

November 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-