AccessGUDID - DEVICE: ImmunoDOT Borrelia Test (00613745050256)

GUDID

Device Identifier (DI) Information

Brand Name: ImmunoDOT Borrelia Test
Version or Model: 800-5025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5025
Company Name: Genbio

Primary DI Number: 00613745050256
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 940425333 *Terms of Use

Device Description: The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test for the qualitative detection of Borrelia antibodies. Both species specific (anti-P39) and related Borrelia burgdorferi antibodies (IgG, IgM, and IgA) are detected in serum as an aid in the diagnosis of Lyme disease.

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?
50555	Borrelia burgdorferi total antibody IVD, kit, immunoblot	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSR	Reagent, Borrelia Serological Reagent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911627	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: 25 tests

Device Record Status

Public Device Record Key: c1fa7f40-d80b-40a7-816e-cd63fd7183d9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016