DBC Pregnenolone ELISA CAN-PRE-4500

GUDID B261CANPRE45000

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

Diagnostics Biochem Canada Inc

Pregnenolone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B261CANPRE45000
• NIH Device Record Key: e34f205a-59b9-4664-93b0-7a28d4129f85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DBC Pregnenolone ELISA
• Version Model Number: CAN-PRE-4500
• Catalog Number: CAN-PRE-4500
• 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	B261CANPRE45000 [Primary]

FDA Product Code

• JNG: Radioimmunoassay, Pregnenolone

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 Pregnenolone ELISA]

• B261CANPRE45000: For the direct quantitative determination of Pregnenolone by an enzyme immunoassay in human seru
• B261CANPRE4500N0: For the quantitative measurement of Pregnenolone in human serum by an ELISA (Enzyme-Linked Immun