Catalog Number

-

Brand Name

SPIFE Nexus Antisera 9/15 Kit

Version/Model Number

552697

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K973040

Product Code

CFF

Product Code Name

Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Public Device Record Key

4dfcaf7f-0e9a-4980-b658-1302714f26c9

Public Version Date

June 02, 2022

Public Version Number

1

DI Record Publish Date

May 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-