ANA Detect ELISA EIA-4117

GUDID 00840239041173

ANA Detect ELISA is a test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro 52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples.

DRG International Inc

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

• Primary Device ID: 00840239041173
• NIH Device Record Key: d192a5b1-d977-424f-b05f-bcd6e6e9a82b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANA Detect ELISA
• Version Model Number: EIA-4117
• Catalog Number: EIA-4117
• Company DUNS: 075150847
• Company Name: DRG International Inc
• 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: 9735647555
• Email: corpoffice@drg-international.com
• Phone: 9735647555
• Email: corpoffice@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840239041173 [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: 2023-09-04
• Device Publish Date: 2023-08-25

Devices Manufactured by DRG International Inc

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• 00084023903579 - Anti-SS-B ELISA: 2023-09-04 Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies against SS-B (La) in human serum o
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• 00840239031402 - Salivary 17-OH Progesterone ELISA: 2023-09-04 An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva.
• 00840239035776 - Anti-Sm ELISA: 2023-09-04 Anti-Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Sm in human serum or plasma.
• 00840239035783 - Anti-RNP/Sm ELISA: 2023-09-04 Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against RNP/Sm in human serum or