Cardiac Muscle Primate

Primary DI
00845533003469
Brand
Cardiac Muscle Primate
Company
ZEUS SCIENTIFIC, INC.
Model
5448L
Catalog number
5448L
Device description
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 monkey heart.
Published
2026-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533003469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533003469008455330034698455330034690845533003469

GMDN Terms#

Term, Definition table
TermDefinition
Striated muscle antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to striated muscle in a clinical specimen, using a fluorescent immunoassay method. It is used as an aid in the diagnosis of skeletal and cardiac muscle autoimmune disorders such as myasthenia gravis (MG) and inflammatory myopathies, and various autoimmune endocrinopathies.

Regulatory Flags#

DUNS number
080953946
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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