AccessGUDID - DEVICE: VARIANT II Hemoglobin A1c (00847817011931)

GUDID

Device Identifier (DI) Information

Brand Name: VARIANT II Hemoglobin A1c
Version or Model: 270-2111NU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2702111NU
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847817011931
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132528295 *Terms of Use

Device Description: VARIANT II Hemoglobin A1c Program Elution Buffer B

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:	No
Prescription Use (Rx):	No
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?
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 [?]
K070452	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d3ae049-3a41-43e2-946f-4497f244828e
Public Version Date: January 31, 2023
Public Version Number: 7
DI Record Publish Date: September 12, 2016