IMMULITE® Systems HCG CONTROL HCG

Basic Information

• Brand Name: IMMULITE® Systems HCG CONTROL HCG
• Primary DI: 00630414953205
• Version / Model: 10385358
• Catalog Number: LCGCM
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• Labeler DUNS: 296822794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 682ca92d-001b-42b2-86bf-5fc9bf39d318

Device Description

HCG - IMMULITE - CTL - 2x2mL

Device Characteristics

• Single Use: Yes
• 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
DHA	SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN	Clinical Chemistry	862.1155	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38262	Total human chorionic gonadotropin IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414953205	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K911796	000

Storage Conditions

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