cobas b 221 SOL THB CALIBRATOR

Basic Information

• Brand Name: cobas b 221 SOL THB CALIBRATOR
• Primary DI: 04015630015504
• Version / Model: 3110923035
• Catalog Number: 3110923035
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0c14ad60-d94e-45b3-ba11-e2fb10d914a4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55865	Full blood count IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630015504	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius