Catalog Number

2702101NU

Brand Name

VARIANT II Hemoglobin A1c

Version/Model Number

270-2101NU

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)

Yes

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

K070452

Product Code

KRZ

Product Code Name

CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT

Public Device Record Key

3bc0d4a3-8595-412b-847a-30bf22c9d8e5

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

-