DBC Estrone ELISA CAN-E-420

GUDID B261CANE4200

For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.

Diagnostics Biochem Canada Inc

Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B261CANE4200
• NIH Device Record Key: b9454bef-4961-4538-9a8e-766d3e009c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBC Estrone ELISA
• Version Model Number: CAN-E-420
• Catalog Number: CAN-E-420
• Company DUNS: 207718438
• Company Name: Diagnostics Biochem Canada Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B261CANE4200 [Primary]

FDA Product Code

• CGF: Radioimmunoassay, Estrone

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 Estrone ELISA]

• B261CANE4208PK0: For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorb
• B261CANE4200: For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorb