Catalog Number

95-458

Brand Name

INVADER

Version/Model Number

INVADER MTHFR 677, 1680 TESTS

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

K100496

Product Code

OMM

Product Code Name

Test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr

Public Device Record Key

a3399ad6-4c65-4077-b38e-9cbaa545e654

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-