AccessGUDID - DEVICE: EZ-SHIGELLA One-Step Shigella species Rapid Test (08305901009155)

GUDID

Device Identifier (DI) Information

Brand Name: EZ-SHIGELLA One-Step Shigella species Rapid Test
Version or Model: 1009-15
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOMERICA, INC.

Primary DI Number: 08305901009155
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 067647321 *Terms of Use

Device Description: The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.

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):	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?
51604	Multiple Shigella species verotoxin 1 & 2 antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of verotoxin 1 and/or verotoxin 2 antigens from one or multiple species of Shigella bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNB	Antisera, All Types, Shigella Spp.

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8ea4450e-0c5e-41d0-b4d2-75581d07b432
Public Version Date: September 02, 2021
Public Version Number: 2
DI Record Publish Date: January 10, 2020