Immco Diagnostics, Inc.

Basic Information

• Brand Name: Immco Diagnostics, Inc.
• Primary DI: 00845714004841
• Version / Model: 6101M-400
• Catalog Number: 6101M-400
• Company Name: IMMCO DIAGNOSTICS, INC.
• Labeler DUNS: 079935300
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 775669b4-5e0d-44b8-b536-56166031bbaa

Device Description

Lyme B. burgdorferi (IgM) Marstripe Test

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
LSR	Reagent, Borrelia Serological Reagent	Microbiology	866.3830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53591	Multiple clinical chemistry protein IVD, kit, immunoblot	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins in a clinical specimen, using an immunoblot method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845714004841	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172254	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			400 determinations

Storage Conditions

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