AccessGUDID - DEVICE: REAG SGNL - EV701 (05055273202694)

GUDID

Device Identifier (DI) Information

Brand Name: REAG SGNL - EV701
Version or Model: EV3601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EV3601
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273202694
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV701 and 1 bottle of Peroxide Reagent. The analyser uses a 1:1 mixture of the two solutions as a working signal reagent - EV701 to generate a chemiluminescent signal which can be detected by the imaging module of the Evidence™ analyser.

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?
58793	Chemiluminescent immunoassay signal generation kit IVD	A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an immunoassay on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled antibodies or antigens of known characterization and may also include reference material to optimise and verify performance of the luminometer instrument.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030360	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
No Device Sizes

Device Record Status

Public Device Record Key: d5eee930-1f26-4949-9ed7-acace5d24d77
Public Version Date: December 21, 2020
Public Version Number: 3
DI Record Publish Date: September 26, 2016