AccessGUDID - DEVICE: ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay (05056080501673)

GUDID

Device Identifier (DI) Information

Brand Name: ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay
Version or Model: R2474096
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMEL EUROPE LIMITED

Primary DI Number: 05056080501673
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 232600853 *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):	No
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?
50923	Escherichia coli 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 antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GMZ	Antigens, All Types, Escherichia Coli

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980507	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 564d7db0-c06d-4ba4-9f5a-23e3e4282bea
Public Version Date: July 29, 2021
Public Version Number: 1
DI Record Publish Date: July 21, 2021