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

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• 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