AccessGUDID - DEVICE: Afinion HbA1c Control (07070060014661)

GUDID

Device Identifier (DI) Information

Brand Name: Afinion HbA1c Control
Version or Model: 1116975
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1116975
Company Name: Abbott Diagnostics Technologies AS

Primary DI Number: 07070060014661
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 515324122 *Terms of Use

Device Description: HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 Control C II, 1 package insert.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
44435	Glycated haemoglobin (HbA1c) IVD, control	A material which is used to verify the performance of an assay intended to be 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Handling Environment Humidity: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b33113b8-6575-4786-ac28-95ecb65b3a18
Public Version Date: May 24, 2019
Public Version Number: 1
DI Record Publish Date: May 16, 2019