IMMCO DIAGNOSTICS

Basic Information

• Brand Name: IMMCO DIAGNOSTICS
• Primary DI: 00845714002229
• Version / Model: 5118S
• Catalog Number: 5118S
• Company Name: IMMCO DIAGNOSTICS, INC.
• Labeler DUNS: 079935300
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: ad6332fc-0d48-4aca-9257-5e16dc74c6a3
• Distribution End Date: 2021-08-31

Device Description

ACA Screen ELISA

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: 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
MID	System, Test, Anticardiolipin Immunological	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54870	Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin 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	00845714002229	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			96 DETERMINATIONS

Storage Conditions

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