Catalog Number

80107

Brand Name

UP20 Positive Control Reagent

Version/Model Number

80107

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2021

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

K051677,K051677

Product Code

DGC

Product Code Name

IGE, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

4075dc92-9ec3-43dc-b79c-7aa08225e5f6

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

June 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-