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

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• 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