AccessGUDID - DEVICE: Glycohemoglobin Bi-Level Controls (00657498000922)

GUDID

Device Identifier (DI) Information

Brand Name: Glycohemoglobin Bi-Level Controls
Version or Model: 0357-201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0357-201
Company Name: STANBIO LABORATORY, L.P.

Primary DI Number: 00657498000922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045361136 *Terms of Use

Device Description: For Use as Human Glycohemoglobin Controls in Quantitative Glycohemoglobin Procedures.

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:	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?
55874	Total haemoglobin (totHb) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) 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
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: fa50e935-0752-4e30-9180-b399bf558b17
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016