AccessGUDID - DEVICE: Immco Diagnostics, Inc. (00845714004841)

GUDID

Device Identifier (DI) Information

Brand Name: Immco Diagnostics, Inc.
Version or Model: 6101M-400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6101M-400
Company Name: IMMCO DIAGNOSTICS, INC.

Primary DI Number: 00845714004841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079935300 *Terms of Use

Device Description: Lyme B. burgdorferi (IgM) Marstripe Test

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSR	Reagent, Borrelia Serological Reagent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172254	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 400 determinations

Device Record Status

Public Device Record Key: 775669b4-5e0d-44b8-b536-56166031bbaa
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 14, 2017