dBest

GUDID 00863545000306

AMERITEK, INC.

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00863545000306
• NIH Device Record Key: 8f245855-c067-4d13-8dcf-afa38e221742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dBest
• Version Model Number: N/A
• Company DUNS: 943032649
• Company Name: AMERITEK, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 4253792580
• Email: info@ameritek.org

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863545000306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001215

FDA Product Code

• JHI: Visual, Pregnancy Hcg, Prescription Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22