Catalog Number

11986082216

Brand Name

Opiates II

Version/Model Number

11986082216

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 24, 2019

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

K060373

Product Code

DJG

Product Code Name

ENZYME IMMUNOASSAY, OPIATES

Public Device Record Key

f27688be-7212-4683-a378-5824b4641ec9

Public Version Date

November 27, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-