ADVIA Centaur® Systems, ACS:180® Systems Calibrator D

Basic Information

• Brand Name: ADVIA Centaur® Systems, ACS:180® Systems Calibrator D
• Primary DI: 00630414124933
• Version / Model: 10311576
• Catalog Number: 672183000
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: b19e6262-e3d3-4a22-8f54-aba6883ea9eb

Device Description

Calibrator D - 6 pack (AFP Cal; CEA Cal)

Device Characteristics

• Single Use: Yes
• 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
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
38221	Multiple tissue-associated protein/tumour marker IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414124933	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P930036	001
P930036	003

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius