AccessGUDID - DEVICE: TRI-SLIDE STOOL BLOOD TEST (B224SB201)

GUDID

Device Identifier (DI) Information

Brand Name: TRI-SLIDE STOOL BLOOD TEST
Version or Model: SB-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SB-20
Company Name: CENOGENICS CORPORATION

Primary DI Number: B224SB201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068288943 *Terms of Use

Device Description: Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding. The Kit Contains: 100 three-section slides with controls. Each section contains two test sites (6 tests/slide) and a positive and negative control set. 300 applicators 6 X 10ml developing solution Product Instructions

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:	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?
54531	Faecal occult blood IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHE	Reagent, Occult Blood

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K761232	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: 35022ff1-c732-4dd1-8034-5c51da4d5291
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: May 27, 2021