Catalog Number

12000577

Brand Name

Amplichek

Version/Model Number

12000577

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

DEN150058

Product Code

PMN

Product Code Name

Assayed external control material for microbiology nucleic acid amplification (NAT) assays

Public Device Record Key

3ba8398c-2b9a-43a4-b27e-dbcb9a2808d7

Public Version Date

July 29, 2021

Public Version Number

6

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-