RF IgM 2Z9291M

GUDID 00845533002561

The Rheumatoid Factor (RF) IgM Test System is intended for the qualitative and semi-quantitative detection of RF IgM class antibody in human sera. The test is intended to be used as an aid in the diagnosis of rheumatoid arthritis and is for In Vitro diagnostic use.

ZEUS SCIENTIFIC, INC.

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533002561
• NIH Device Record Key: 321d80c4-4152-4520-beb6-6f6a5e616ac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RF IgM
• Version Model Number: 2Z9291M
• Catalog Number: 2Z9291M
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, 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: 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

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	00845533002561 [Primary]

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: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [RF IgM ]

• 00845533002578: The Rheumatoid Factor (RF) IgM Test System is intended for the qualitative and semi-quantitative
• 00845533002561: The Rheumatoid Factor (RF) IgM Test System is intended for the qualitative and semi-quantitative