Cardiac Muscle (Rat) 5448RL

GUDID 00845533002882

Demonstration of Cardiac Muscle Antibody (CMA) by utilizing the indirect fluorescent antibody method enables serologic assessment or possible detection of cardiac disease. The presence of a (histologically defined) circulating antibody to one or more of the cardiac muscle antigens can aid in patient diagnosis and prognosis of such disease as; rheumatic fever, myocardial infarction and a variety of post-cardiotomy states. The substrate utilized in this kit is sections of rat heart.

ZEUS SCIENTIFIC, INC.

Striated muscle antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00845533002882
• NIH Device Record Key: e7d0e38d-069d-46f7-a4ea-0247cbe9521a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac Muscle (Rat)
• Version Model Number: 5448RL
• Catalog Number: 5448RL
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533002882 [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: 2026-02-26
• Device Publish Date: 2026-02-18

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