Testosterone Luminescence Immunoassay RE62039.

GUDID 04049325006546

Testosterone Luminescence Immunoassay - 10 x 96 Determinations

IBL International GmbH

Total testosterone IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04049325006546
• NIH Device Record Key: 970f1729-3c44-4f54-be3b-df031f58be97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Testosterone Luminescence Immunoassay
• Version Model Number: RE62039.
• Catalog Number: RE62039.
• Company DUNS: 312694785
• Company Name: IBL International GmbH
• 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: 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: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049325006546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033786

FDA Product Code

• JIT: Calibrator, Secondary

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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [Testosterone Luminescence Immunoassay]

• 04049325006546: Testosterone Luminescence Immunoassay - 10 x 96 Determinations
• 04049325003545: Testosterone Luminescence Immunoassay - 96 Determinations