Pregnenolone ELISA 11-PRNHU-E01

GUDID B24211PRNHUE010

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

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Pregnenolone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B24211PRNHUE010
• NIH Device Record Key: 17332f19-e5ba-4e3f-bbae-1a16ab9b6c14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pregnenolone ELISA
• Version Model Number: 11-PRNHU-E01
• Catalog Number: 11-PRNHU-E01
• Company DUNS: 784143778
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.com
• Phone: 8005925726
• Email: cs@alpco.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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B24211PRNHUE010 [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: 2023-06-02
• Device Publish Date: 2023-05-25

On-Brand Devices [Pregnenolone ELISA]

• B24211PREHUE010: Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using h
• B24211PRNHUE010: Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using h