EL-ANA PROFILES: ANA/4 105-002

GUDID 00854473003309

ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 24 TESTS OF 4 INDIVIDUAL ANTIGENS

THERA-TEST LABORATORIES, INC

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00854473003309
• NIH Device Record Key: b6f11fff-7560-4912-badf-03184f473109
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EL-ANA PROFILES: ANA/4
• Version Model Number: 105-002
• Catalog Number: 105-002
• Company DUNS: 194336954
• Company Name: THERA-TEST LABORATORIES, 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: false
• 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: false
• OTC Over-The-Counter: false

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	00854473003309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051066

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: 2018-07-20
• Device Publish Date: 2018-06-19

On-Brand Devices [EL-ANA PROFILES: ANA/4]

• 00854473003309: ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 24 TESTS OF 4 INDIVIDUAL ANTIGENS
• 00854473003293: ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 60 TESTS OF 4 INDIVIDUAL ANTIGENS