ADVIA Centaur® FSH MCM

Basic Information

• Brand Name: ADVIA Centaur® FSH MCM
• Primary DI: 00630414126210
• Version / Model: 10311617
• Catalog Number: 672418000
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 28072a62-1eb7-430f-b0a5-9099c2d0d702

Device Description

Follicular Stimulating Hormone 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
CGJ	RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE	Clinical Chemistry	862.1300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38254	Follicle stimulating hormone (FSH) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414126210	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K904649	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store Upright, Protect from Light, Do not freeze, Resuspend.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius