AccessGUDID - DEVICE: HbA1C CONTROL (05055273208818)

GUDID

Device Identifier (DI) Information

Brand Name: HbA1C CONTROL
Version or Model: HA5072
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HA5072
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273208818
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: This product is intended for in vitro diagnostic use in the quality control of HbA1c on clinical chemistry systems.

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?
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 [?]
K131999	000

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: The reconstituted control is stable for 1 month when stored refrigerated at +2°C to +8°C.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1fa3ad9-0b15-4dce-8fa2-04c391c6605d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016