AccessGUDID - DEVICE: AST (SGOT) REAGENT SET (UV-KINETIC METHOD) (10673486001174)

GUDID

Device Identifier (DI) Information

Brand Name: AST (SGOT) REAGENT SET (UV-KINETIC METHOD)
Version or Model: A560-240
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A560-240
Company Name: TECO DIAGNOSTICS

Primary DI Number: 10673486001174
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185067774 *Terms of Use

Device Description: The AST (SGOT) REAGENT SET (UV-KINETIC METHOD) is used for the quantitative determination of Aspartate Aminotransferase (AST) in human serum.

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?
52955	Total aspartate aminotransferase (AST) 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 total aspartate aminotransferase (AST) 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 [?]
K875071	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: e4eeeca5-6574-4594-b1dd-ad62a693edd3
Public Version Date: July 28, 2023
Public Version Number: 1
DI Record Publish Date: July 20, 2023