ENA Screen ELISA EIA-3571

GUDID 04048474035711

ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma .samples.

DRG Instruments Gesellschaft mit beschränkter Haftung

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

• Primary Device ID: 04048474035711
• NIH Device Record Key: 715dc62b-be56-4673-8dca-2ad9df1cc414
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENA Screen ELISA
• Version Model Number: EIA-3571
• Catalog Number: EIA-3571
• 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: 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: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048474035711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955134

FDA Product Code

• LLL: EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-30
• Device Publish Date: 2019-06-10

On-Brand Devices [ENA Screen ELISA]

• 00404847435719: ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies agai
• 04048474035711: ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies agai