AccessGUDID - DEVICE: Fructosamine (00811727013521)

GUDID

Device Identifier (DI) Information

Brand Name: Fructosamine
Version or Model: 12-F7546-55
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12-F7546-55
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727013521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: This reagent is intended for the quantitative determination of fructosamine in human serum. For in vitro diagnostic use only.

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):	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?
53274	Fructosamine IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the glycated serum protein fructosamine in a clinical specimen, using a spectrophotometry method. It is typically used to aid in monitoring of average glucose levels and glycaemic control in diabetic patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	Assay, Glycosylated Hemoglobin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993590	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: e7e466e7-2f9d-4c52-8603-317579ff572d
Public Version Date: February 16, 2024
Public Version Number: 5
DI Record Publish Date: August 31, 2016