AccessGUDID - DEVICE: ADVIA® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents (00630414553146)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents
Version or Model: 10283342
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6860477
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414553146
Issuing Agency: GS1
Commercial Distribution End Date: October 03, 2019
Device Count: 6
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 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?
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
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
Special Storage Condition, Specify: Do not freeze
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: 19e09659-391a-4969-a2d6-eaf2167b8113
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: October 02, 2019