EL-RF/3 IgM, IgG, IgA 303-305

GUDID 00854473003033

RHEUMATOID FACTOR ELISA TEST KIT, IgM, IgG, IgA, 60 Tests

THERA-TEST LABORATORIES, INC

Multiple rheumatoid arthritis-associated antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00854473003033
• NIH Device Record Key: 453cdcfe-b7ea-43f8-af8b-612b8f7e59ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EL-RF/3 IgM, IgG, IgA
• Version Model Number: 303-305
• Catalog Number: 303-305
• 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	00854473003033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941398

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: 2018-03-29
• Device Publish Date: 2016-08-15

Devices Manufactured by THERA-TEST LABORATORIES, INC

• 00854473003347 - EL-ANA PROFILES: ANA/8: 2023-07-14 ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 40 TEST OF 8 INDIVIDUAL ANITGENS
• 00854473003354 - EL-ANA PROFILES: ANA/6: 2023-07-14 ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 60 TESTS OF 6 INDIVIDUAL ANTIGENS
• 00854473003323 - EL-Anti-SARS-CoV-2 IgM: 2023-07-07 ANTI-SARS-CoV-2 IgM ANTIBODY ELISA TEST KIT, 96 TESTS
• 00854473003330 - EL-Anti-SARS-CoV-2 IgG: 2023-07-07 ANTI-SARS-CoV-2 IgG ANTIBODY ELISA TEST KIT, 96 TESTS
• 00854473003316 - EL-Anti-SARS-CoV-2: 2020-05-12 ANTI-SARS-COV-2 ANTIBODY ELISA TEST KIT, 192 TESTS
• 00854473003309 - EL-ANA PROFILES: ANA/4: 2018-07-20 ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 24 TESTS OF 4 INDIVIDUAL ANTIGENS
• 00854473003002 - EL-ANA PROFILES: EL-ANAscr: 2018-03-29 ANTI-NUCLEAR ANTIBODY SCREEN ELISA TEST KIT, 96 TESTS
• 00854473003019 - EL-anti-CCP/2: 2018-03-29 ANTI-CCP/2 ANTIBODY ELISA TEST KIT, 192 TESTS