AccessGUDID - DEVICE: ADVIA Chemistry P5PL

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Chemistry P5PL_c Reagent
Version or Model: 10729782
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10729782
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414008950
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc

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:	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?
52904	Multiple clinical chemistry enzyme IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIT	Nadh oxidation/nad reduction, ast/sgot
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: 7db792dd-055f-49ef-8a5d-d542c4bf00d5
Public Version Date: December 08, 2022
Public Version Number: 3
DI Record Publish Date: November 04, 2021