AccessGUDID - DEVICE: Alere Afinion™ HbA1c (07070060005683)

GUDID

Device Identifier (DI) Information

Brand Name: Alere Afinion™ HbA1c
Version or Model: 1115015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1115015
Company Name: Abbott Diagnostics Technologies AS

Primary DI Number: 07070060005683
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 515324122 *Terms of Use

Device Description: Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 Test Cartridges. 1 Package Insert. DI covers Alere Afinion HbA1c and Afinion HbA1c.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53316	Glycated haemoglobin (HbA1c) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	Assay, Glycosylated Hemoglobin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 58257f34-bebd-435b-bc72-05f746d12c09
Public Version Date: May 09, 2019
Public Version Number: 4
DI Record Publish Date: September 16, 2016