Atellica IM AB12

Basic Information

• Brand Name: Atellica IM AB12
• Primary DI: 00630414245720
• Version / Model: 10733001
• Catalog Number: 10733001
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-19
• Public Version: 3
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 182f100d-05d0-4dc1-b260-5d58dfd8fbf8

Device Description

Active-B12 (AB12) Atellica IM - RGT 100T

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: Yes
• 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
CDD	RADIOASSAY, VITAMIN B12	Clinical Chemistry	862.1810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62120	Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of holotranscobalamin (holoTC), also known as active-B12, in a clinical specimen, using a chemiluminescent immunoassay. It is used to aid in the diagnosis and treatment of vitamin B12 deficiency.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414245720	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160757	000

Storage Conditions

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