Catalog Number

OPJC05

Brand Name

N FLC SUPPLEMENTARY REAGENT

Version/Model Number

10873660

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

K171742

Product Code

DEH

Product Code Name

LAMBDA, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

729b6166-9d6d-46a8-b9a2-79d3f315b8c3

Public Version Date

November 18, 2021

Public Version Number

4

DI Record Publish Date

October 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-