AccessGUDID - DEVICE: IDG/Sanzay (00850053916038)

GUDID

Device Identifier (DI) Information

Brand Name: IDG/Sanzay
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C065
Company Name: IDG/SANZAY Corporation

Primary DI Number: 00850053916038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 948875013 *Terms of Use

Device Description: For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reagents are used in routine examination and monitoring of therapy and relapses.

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?
52953	Aspartate aminotransferase (AST) isoenzyme 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 qualitative and/or quantitative detection of one or multiple aspartate aminotransferase (AST) isoenzymes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981650	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: 50 Milliliter
Total Volume: 100 Milliliter
Total Volume: 125 Milliliter
Total Volume: 240 Milliliter
Total Volume: 1 Liter
Total Volume: 250 Milliliter
Total Volume: 500 Milliliter

Device Record Status

Public Device Record Key: 7755b945-c9b2-4959-8437-d40358a7292a
Public Version Date: January 15, 2024
Public Version Number: 1
DI Record Publish Date: January 05, 2024