ADVIA Centaur® VALP MCM

Basic Information

• Brand Name: ADVIA Centaur® VALP MCM
• Primary DI: 00630414527369
• Version / Model: 10322232
• Catalog Number: 5261307
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: f18e4ae3-d5a2-40a5-aa2b-c3fc9aaeb082

Device Description

Valproic Acid Master Curve Material Set - CENTAUR - CONS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DKB	CALIBRATORS, DRUG MIXTURE	Clinical Toxicology	862.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55432	Valproic acid therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug valproic acid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414527369	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K013959	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: store upright
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius