Cand-Tec

Basic Information

• Brand Name: Cand-Tec
• Primary DI: 08600000686024
• Version / Model: CO3/5
• Catalog Number: CO3/5
• Company Name: Ramco Laboratories, Inc.
• Labeler DUNS: 082013897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-23
• Public Version: 2
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: f7d95a9b-82f8-4810-9ce0-a8bd77c9be0b

Device Description

Candida Detection

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHK	ANTIGEN, ID, CANDIDA ALBICANS	Microbiology	866.3165	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52070	Multiple candida antigen IVD, kit, rapid agglutination, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of Candida yeast (e.g., Candida albicans, Candida tropicalis and/or Candida parapsilosis) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08600000686024	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K823016	000