Free Testosterone ELISA EIA-6101

GUDID 04048474061017

The device is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone in human serum.

DRG Instruments Gesellschaft mit beschränkter Haftung

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• Primary Device ID: 04048474061017
• NIH Device Record Key: e2754dbf-d84e-4210-9e3e-c6677aacea31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Free Testosterone ELISA
• Version Model Number: EIA-6101
• Catalog Number: EIA-6101
• Company DUNS: 317134468
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• 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: true
• 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: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048474061017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181017

FDA Product Code

• CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone

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: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [Free Testosterone ELISA]

• 04048474046380: For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human se
• 04048474061017: The device is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone