IMMCO DIAGNOSTICS

Basic Information

• Brand Name: IMMCO DIAGNOSTICS
• Primary DI: 00845714004001
• Version / Model: 2252
• Catalog Number: 2252
• Company Name: IMMCO DIAGNOSTICS, INC.
• Labeler DUNS: 079935300
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-27
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e921b7d9-6a05-424a-a8a9-329dbbbf038e

Device Description

cANCA Positive Control

Device Characteristics

• Single Use: No
• 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: Yes
• 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
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41386	Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) 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 anti-neutrophil cytoplasmic antibodies (ANCA) to proteinase 3 (PR3) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845714004001	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982898	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			.5 ml

Storage Conditions

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