AccessGUDID - DEVICE: ADVIA® Chemistry P5P Pyridoxal-5-Phosphate Reagents (00630414501789)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry P5P Pyridoxal-5-Phosphate Reagents
Version or Model: 10326245
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7371282
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414501789
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Pyridoxal-5-Phosphate Reagents

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?
52925	Alanine aminotransferase (ALT) 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 alanine aminotransferase (ALT) 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 [?]
K991576	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: Do not freeze

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a558e51-ec2e-447b-875d-7f7cd37b6ade
Public Version Date: December 10, 2021
Public Version Number: 6
DI Record Publish Date: February 15, 2018