AccessGUDID - DEVICE: Dimension® Flex® reagent cartridge ALTI (00842768034336)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex® reagent cartridge ALTI
Version or Model: 10475530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF143
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768034336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Alanine Aminotransferase Flex® reagent cartridge, 240 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?
52924	Alanine aminotransferase (ALT) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alanine aminotransferase (ALT) in a clinical specimen, using a spectrophotometry method.	Active	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 61fa3d0e-ed38-4093-8300-97ea80c1b503
Public Version Date: September 13, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2020