Cand-Tec CO3/5

GUDID 08600000686024

Candida Detection

Ramco Laboratories, Inc.

Candida albicans/C. tropicalis/C. parapsilosis antigen IVD, kit, agglutination, rapid

• Primary Device ID: 08600000686024
• NIH Device Record Key: f7d95a9b-82f8-4810-9ce0-a8bd77c9be0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cand-Tec
• Version Model Number: CO3/5
• Catalog Number: CO3/5
• Company DUNS: 082013897
• Company Name: Ramco Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(281)313-1200
• Email: ramcolab@aol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08600000686024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823016

FDA Product Code

• LHK: ANTIGEN, ID, CANDIDA ALBICANS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-01
• Device Publish Date: 2019-03-23

On-Brand Devices [Cand-Tec]

• 08600000686024: Candida Detection
• 78600000686023: Candida Detection
• 28600000686028: Candida Detection
• 18600000686021: Candida Detection