AccessGUDID - DEVICE: C. DIFFICILE TOX-B TEST (00857031002073)

GUDID

Device Identifier (DI) Information

Brand Name: C. DIFFICILE TOX-B TEST
Version or Model: 30399U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TECHLAB, INC.

Primary DI Number: 00857031002073
Issuing Agency: GS1
Commercial Distribution End Date: May 04, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 614218634 *Terms of Use

Device Description: The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history.

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?
63037	Clostridium difficile antigen IVD, kit, cell culture assay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of the cytotoxicity of antigens to Clostridium difficile bacteria [e.g., toxin A and/or toxin B] in a clinical specimen, using a cell culture assay.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLH	Reagents, Clostridium Difficile Toxin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 4c721a1c-045b-4f1a-abe9-3dc80975a98f
Public Version Date: August 15, 2023
Public Version Number: 2
DI Record Publish Date: January 24, 2020