Immco Diagnostics

Basic Information

• Brand Name: Immco Diagnostics
• Primary DI: 05391516746595
• Version / Model: 5175
• Catalog Number: 5175
• Company Name: CLARK LABORATORIES, INC.
• Labeler DUNS: 623214079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-25
• Public Version: 1
• Public Version Date: 2019-11-04
• Public Version Status: New
• Public Device Record Key: b9a25f48-ae05-4560-a965-c5a48a19b307

Device Description

ImmuLisa™ Enhanced ANA Screen

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54809	Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516746595	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K954723	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			96 Tests

Storage Conditions

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