Catalog Number

80-4065P10K

Brand Name

SPOTCHECK

Version/Model Number

80-4065P10K

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

K970277

Product Code

KQP

Product Code Name

Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

Public Device Record Key

ede6337a-fe66-4ab5-b14b-2ed02be49768

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-