AccessGUDID - DEVICE: Hemoglobin Variants System (00847817007163)

GUDID

Device Identifier (DI) Information

Brand Name: Hemoglobin Variants System
Version or Model: 250-0014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2500014
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847817007163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132528295 *Terms of Use

Device Description: Hemoglobin Variants System Cation Exchange Mini-Columns

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?
59807	Inherited haemoglobinopathy 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 to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDM	INSTRUMENTATION, HIGH PRESSURE LIQUID CHROMATOGRAPHY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171664	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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0aa67f50-1b8a-40a2-85fa-232d80929a22
Public Version Date: January 31, 2023
Public Version Number: 2
DI Record Publish Date: July 01, 2020