DM EXL LOCI BRAHMS PCT Cal Kit

Basic Information

• Brand Name: DM EXL LOCI BRAHMS PCT Cal Kit
• Primary DI: 00630414238708
• Version / Model: 11354448
• Catalog Number: RC648
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 1
• Public Version Date: 2022-11-23
• Public Version Status: New
• Public Device Record Key: 48cd3eb5-6eb7-48ca-a422-9ddca0b2199d

Device Description

Procalcitonin (PCT) DM EXL LOCI BRAHMS - Cal Kit

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
54314	Procalcitonin (PCT) 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 procalcitonin (PCT) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00630414295039	GS1
Primary	00630414238708	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius