Beckman Coulter PK CMV-PA SYSTEM Control Set

Basic Information

• Brand Name: Beckman Coulter PK CMV-PA SYSTEM Control Set
• Primary DI: 00850212007058
• Version / Model: 240226
• Catalog Number: PA2302
• Company Name: FUJIREBIO DIAGNOSTICS, INC.
• Labeler DUNS: 079291908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 3ab6e28b-78c2-452e-915d-7c138c34c45f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
MZE	Test,Donor,Cmv	Unknown		2

GMDN Terms

Code	Name	Definition	Implantable	Status
49734	Cytomegalovirus (CMV) total antibody 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 antibodies to cytomegalovirus (CMV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850212007058	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK070030	0
BK200476	0

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size Type = Units per Kit; Units = 12; Unit of measure =4mL

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius