AccessGUDID - DEVICE: ALT (05055273200225)

GUDID

Device Identifier (DI) Information

Brand Name: ALT
Version or Model: AL3875
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AL3875
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273200225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: An ALT test system is a device intended for the quantitative in vitro determination of of Alanine Aminotransferase (ALT) activity in serum and 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:	Yes
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?
52923	Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923510	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
Special Storage Condition, Specify: Reagent is stable for 7 days at +2 to +8ºC

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ea35b52-7de6-4756-b952-3f415df1e170
Public Version Date: January 24, 2019
Public Version Number: 1
DI Record Publish Date: December 24, 2018