Afinion HbA1c - Hemoglobin A1c test kit. Intended use: For - Abbott Diagnostics Technologies AS

Duns Number:515324122

Device Description: Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 test cartridges, 1 package insert

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More Product Details

Catalog Number

1116974

Brand Name

Afinion HbA1c

Version/Model Number

1116974

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K171650

Product Code Details

Product Code

JFY

Product Code Name

Enzymatic Method, Creatinine

Device Record Status

Public Device Record Key

e0c52daf-24e7-4318-ad9b-477856bb8b69

Public Version Date

May 24, 2019

Public Version Number

1

DI Record Publish Date

May 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT DIAGNOSTICS TECHNOLOGIES AS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 5