Salivary Testosterone ELISA SLV-3013

GUDID 04048474030136

The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

DRG Instruments Gesellschaft mit beschränkter Haftung

Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA) Total testosterone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04048474030136
• NIH Device Record Key: f7ea007d-86de-4e34-9566-ba73e4bd192f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salivary Testosterone ELISA
• Version Model Number: SLV-3013
• Catalog Number: SLV-3013
• 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	04048474030136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052649

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 [Salivary Testosterone ELISA]

• 00404847430134: The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnosti
• 04048474030136: The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnosti