AccessGUDID - DEVICE: ImmunoDOT Borrelia Positive Control (00613745039053)

GUDID

Device Identifier (DI) Information

Brand Name: ImmunoDOT Borrelia Positive Control
Version or Model: 800-3905
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3905
Company Name: Genbio

Primary DI Number: 00613745039053
Issuing Agency: GS1
Commercial Distribution End Date: August 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 940425333 *Terms of Use

Device Description: This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.

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:	Yes
Prescription Use (Rx):	No
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?
50562	Borrelia burgdorferi immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Borrelia burgdorferi bacteria in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSR	Reagent, Borrelia Serological Reagent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911590	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: 0.1 mL

Device Record Status

Public Device Record Key: 4b65fffe-3877-45e8-a45a-be61daa38160
Public Version Date: August 29, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2016