Capture-CMV Control set

Basic Information

• Brand Name: Capture-CMV Control set
• Primary DI: 10888234001249
• Version / Model: 0066239
• Catalog Number: 0066239
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 835bd600-b11c-4fe0-9e04-8e66fc9e36ff

Device Description

The Capture-CMV Control set is composed of both negative and weak positive control material to control the Capture-CMV test.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
LJO	Antigen, Iha, Cytomegalovirus	Microbiology	866.3175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49710	Cytomegalovirus (CMV) antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234001249	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K910003	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 10 Degrees Celsius