Catalog Number

2702412

Brand Name

VARIANT II TURBO

Version/Model Number

270-2412

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040872

Product Code

LCP

Product Code Name

ASSAY, GLYCOSYLATED HEMOGLOBIN

Public Device Record Key

64958db5-b9f5-4193-a20a-e1b3c5e16848

Public Version Date

July 29, 2021

Public Version Number

6

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-