ADVIA Chemistry Lithium_2 (LITH_2) reagents

Basic Information

• Brand Name: ADVIA Chemistry Lithium_2 (LITH_2) reagents
• Primary DI: 00630414288178
• Version / Model: 11532400
• Catalog Number: 11532400
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-27
• Public Version: 2
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: b75a6575-dc86-4e1b-b2f9-5bd54d900a61

Device Description

Lithium_2 (LITH_2) ADVIA Chemistry - RGT 200T

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
NDW	Assay, porphyrin, spectrophotometry, lithium	Clinical Toxicology	862.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55405	Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug lithium in a clinical specimen, using an atomic spectroscopy method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414288178	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K050374	000

Storage Conditions

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