AccessGUDID - DEVICE: Sure-Vue (00613647000311)

GUDID

Device Identifier (DI) Information

Brand Name: Sure-Vue
Version or Model: 23-200-278
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 23200278
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647000311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: Sure-Vue Signature Cryptosporidium and Giardia Control Kit

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:	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?
47360	Multiple faecal parasite antigen 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 one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTR	KIT, QUALITY CONTROL FOR CULTURE MEDIA

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: 5aac1faa-05ca-4fad-8fd3-4362af3c2ea2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016