IMMCO DIAGNOSTICS

Basic Information

• Brand Name: IMMCO DIAGNOSTICS
• Primary DI: 00845714003646
• Version / Model: 2160
• Catalog Number: 2160
• Company Name: IMMCO DIAGNOSTICS, INC.
• Labeler DUNS: 079935300
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 726a1e04-58f3-4509-ad3a-e5354e13eafb

Device Description

Primate Smooth Muscle Slide

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
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54909	Endomysium antibody (EMA) 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 anti-endomysial antibodies (anti-EMA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845714003646	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K912551	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6 wells

Storage Conditions

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