ANA Combi (ANA-8-Profile) ELISA EIA-3563

GUDID 00404847435634

ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies directed against RNP-70, RNP/Sm, Sm, SS-A (52 and 60 kDa), SS-B, Scl-70, Centromere B and Jo-1 in human serum or plasma.

DRG Instruments Gesellschaft mit beschränkter Haftung

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00404847435634
• NIH Device Record Key: 69d24f2e-abae-4405-9a09-571978be8bbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANA Combi (ANA-8-Profile) ELISA
• Version Model Number: N/A
• Catalog Number: EIA-3563
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00404847435634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030929

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: 2019-06-18
• Device Publish Date: 2019-06-10

On-Brand Devices [ANA Combi (ANA-8-Profile) ELISA]

• 00404847435634: ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies directed
• 04048474035636: ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies directed