AccessGUDID - DEVICE: Echovirus Negative Control (B110ECN44100)

GUDID

Device Identifier (DI) Information

Brand Name: Echovirus Negative Control
Version or Model: ECN-4410
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ECN-4410
Company Name: Bion Enterprises, Ltd.

Primary DI Number: B110ECN44100
Issuing Agency: HIBCC
Commercial Distribution End Date: January 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 024824641 *Terms of Use

Device Description: No description.

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:	No
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?
48552	Multiple enterovirus 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 one or multiple virus serotypes from within the enterovirus family, in a clinical specimen. Enteroviruses intended to be detected may include Coxsackie viruses subgroups A and B, polioviruses, echoviruses and/or enteroviruses type 68-71.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNI	Antisera, Neutralization, Echovirus 1-34

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: 3a2adcaf-9435-4827-98f4-f2f5a8154e82
Public Version Date: March 04, 2020
Public Version Number: 3
DI Record Publish Date: September 12, 2016