DBC Free Testosterone ELISA CAN-FTE-260LC8

GUDID B261CANFTE260LC80

For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use.

Diagnostics Biochem Canada Inc

Free testosterone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B261CANFTE260LC80
• NIH Device Record Key: a19f7c8b-1e9d-49db-a815-24deb54c68e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBC Free Testosterone ELISA
• Version Model Number: CAN-FTE-260LC8
• Catalog Number: CAN-FTE-260LC8
• Company DUNS: 207718438
• Company Name: Diagnostics Biochem Canada 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com
• Phone: 1-519-681-8731
• Email: dbc@dbc-labs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B261CANFTE260LC80 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030730

FDA Product Code

• CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone

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: 2022-11-18
• Device Publish Date: 2022-11-10

On-Brand Devices [DBC Free Testosterone ELISA]

• B261CANFTE260LC80: For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human
• B261CANFTE2600: For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human