Catalog Number

8021-400-M-P-R

Brand Name

MeDiCa

Version/Model Number

8021-400-M-P-R

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K831100

Product Code

DBL

Product Code Name

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Public Device Record Key

d520204d-59b5-4331-b28e-f83313e02d6b

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

December 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-