Atellica CH IgM_2

Basic Information

• Brand Name: Atellica CH IgM_2
• Primary DI: 00630414595627
• Version / Model: 11097620
• Catalog Number: 11097620
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-21
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 54ff0b5f-ce91-4b2a-a155-f37c497b8d39

Device Description

Immunoglobulin M ( IgM_2) Atellica CH - RGT 720T

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
CFN	METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)	Immunology	866.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53793	Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414595627	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992662	000

Storage Conditions

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