Atellica CH LDLC CAL

Basic Information

• Brand Name: Atellica CH LDLC CAL
• Primary DI: 00630414610870
• Version / Model: 11537241
• Catalog Number: 11537241
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2022-07-08
• Public Version: 1
• Public Version Date: 2022-07-18
• Public Version Status: New
• Public Device Record Key: f4d24cd1-6ec9-48ff-bd1e-b5b25abb016b

Device Description

LDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL

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
JIT	Calibrator, secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41728	Low density lipoprotein (LDL) cholesterol IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00630414305134	GS1
Primary	00630414610870	GS1

Customer Contacts

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

Storage Conditions

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