AccessGUDID - DEVICE: C. DIFFICILE TOXIN ANTITOXIN KIT (00857031002066)

GUDID

Device Identifier (DI) Information

Brand Name: C. DIFFICILE TOXIN ANTITOXIN KIT
Version or Model: T5000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECHLAB, INC.

Primary DI Number: 00857031002066
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 614218634 *Terms of Use

Device Description: The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the 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 [?]
K923463	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: 9c3ef5f9-0d22-4dfd-86f2-a548247c03c0
Public Version Date: February 03, 2020
Public Version Number: 1
DI Record Publish Date: January 24, 2020