Catalog Number

980310

Brand Name

APC/Fire™ 750 anti-human CD38

Version/Model Number

980310

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MVU

Product Code Name

Reagents, Specific, Analyte

Public Device Record Key

7e65c4a5-a2d4-4393-86fa-5649b062e80c

Public Version Date

April 20, 2022

Public Version Number

1

DI Record Publish Date

April 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-