AccessGUDID - DEVICE: IDG/Sanzay (00850053916151)

GUDID

Device Identifier (DI) Information

Brand Name: IDG/Sanzay
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C403
Company Name: IDG/SANZAY Corporation

Primary DI Number: 00850053916151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 948875013 *Terms of Use

Device Description: For the in vitro quantitative determination of Triglycerides in serum or plasma.

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):	Yes
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?
53462	Triglyceride 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 quantitative measurement of triglycerides in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K880628	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
Total Volume: 100 Milliliter
Total Volume: 120 Milliliter
Total Volume: 240 Milliliter
Total Volume: 250 Milliliter
Total Volume: 480 Milliliter
Total Volume: 500 Milliliter
Total Volume: 1 Liter

Device Record Status

Public Device Record Key: 203c7d2e-4162-40b4-af42-00e9ebdacd29
Public Version Date: January 22, 2024
Public Version Number: 1
DI Record Publish Date: January 12, 2024