Catalog Number

-

Brand Name

IMMY

Version/Model Number

CL1001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K791381,K791381

Product Code

GMG

Product Code Name

Antigen, Latex Agglutination, Coccidioides Immitis

Public Device Record Key

b2f46a60-112e-44ca-a547-ea9ded46d8b5

Public Version Date

March 28, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-