Atellica IM Androstenedione MCM

Basic Information

• Brand Name: Atellica IM Androstenedione MCM
• Primary DI: 00630414285559
• Version / Model: 11200557
• Catalog Number: 11200557
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-04
• Public Version: 3
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 1b88006c-97d8-49ca-92fd-cbd67510572e

Device Description

Androstenedione (Andro) Atellica IM - Master Curve Material 5x1x1.0mL

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: Yes
• 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
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41780	Androstenedione IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of androstenedione in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414285559	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store below -20 deg C, Store Upright, Protect from Light & Keep Frozen Until Use