AccessGUDID - DEVICE: PRODESSE (15420045506350)

GUDID

Device Identifier (DI) Information

Brand Name: PRODESSE
Version or Model: PROGASTRO SSCS ASSAY
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 303278
Company Name: Hologic, Inc.

Primary DI Number: 15420045506350
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *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:	Yes
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?
47381	Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria genera associated with gastrointestinal diseases, in a clinical specimen, using a nucleic acid technique (NAT). Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLH	REAGENTS, CLOSTRIDIUM DIFFICILE TOXIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123274	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: d834b403-8702-448f-a03f-f2945fc33bbf
Public Version Date: December 18, 2023
Public Version Number: 5
DI Record Publish Date: April 15, 2016