ARGENE® CINAkit HCMV ppUL83 US

Basic Information

• Brand Name: ARGENE® CINAkit HCMV ppUL83 US
• Primary DI: 03573026390273
• Version / Model: 19-0028US
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-17
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8eeb3922-77fe-45d3-85de-a8f14e50d652
• Distribution End Date: 2018-05-24

Device Description

Argene CINAKit is intended for use as an aid in the diagnosis of Cytomegalovirus (CMV) infection by the qualitative detection of CMV pp65 antigen by indirect immunofluore scence

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
GQH	Antigen, Cf (Including Cf Control), Cytomegalovirus	Microbiology	866.3175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49707	Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03573026390273	GS1

Premarket Submissions

Submission Number	Supplement Number
K982311	000

Storage Conditions

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