AccessGUDID - DEVICE: ADVIA® Chemistry FRUC Reagents (00630414558073)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry FRUC Reagents
Version or Model: 10361941
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4862501
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414558073
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Fructosamine - ADVIA Chem. - RGT - 200 tests

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?
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 [?]
K131307	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
Special Storage Condition, Specify: Do not freeze
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: 9201a495-eeee-4438-84ee-70273bf3d989
Public Version Date: July 10, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2016