ENA-6-Profile ELISA EIA-2780

GUDID 04048474027808

The DRG ENA Profile-6 ELISA test system is a semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of this autoantibody profile in the diagnosis and treatment of autoimmune connective tissue disorders

DRG Instruments Gesellschaft mit beschränkter Haftung

Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04048474027808
• NIH Device Record Key: 0cfbc11f-2572-48e3-879d-83f72893050f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENA-6-Profile ELISA
• Version Model Number: EIA-2780
• Catalog Number: EIA-2780
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048474027808 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941409

FDA Product Code

• LJM: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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: 2023-09-06
• Device Publish Date: 2023-08-29

On-Brand Devices [ENA-6-Profile ELISA]

• 04048474027808: The DRG ENA Profile-6 ELISA test system is a semi-quantitative immunoassays for the detection of
• 04048474039016: The Schistosoma mansoni IgG ELISA is intended for the qualitative determination of IgG class ant