Catalog Number

-

Brand Name

Anti-Candida albicans IFA (IgM)

Version/Model Number

FI 2861-1010 M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 11, 2018

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

-

Product Code

LSG

Product Code Name

Candida Species, Antibody Detection

Public Device Record Key

da38b9c4-757c-4b33-a762-62b2e8e9095d

Public Version Date

September 14, 2018

Public Version Number

3

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-