AccessGUDID - DEVICE: SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -) (05055273216387)

GUDID

Device Identifier (DI) Information

Brand Name: SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)
Version or Model: SR10345
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SR10345
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273216387
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi.

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):	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?
50570	Borrelia burgdorferi immunoglobulin G (IgG)/IgM 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) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi bacteria in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MJY	Kit, Serological, Negative Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 3f210e40-4310-4ca4-9c38-4209aa494162
Public Version Date: January 30, 2020
Public Version Number: 1
DI Record Publish Date: January 22, 2020