FDA.reportPublic FDA data

Glomerular Basement Membrane (Primate Kidney)

Primary DI
00845533002028
Brand
Glomerular Basement Membrane (Primate Kidney)
Company
ZEUS SCIENTIFIC, INC.
Model
5648L
Catalog number
5648L
Device description
Demonstration of Glomerular Basement Membrane antibodies (GBM), by immunofluorescent methods may enable serologic assessment and possible detection of kidney disease. The presence of a histologically defined circulating antibody to the glomerular basement membrane can aid in the patient diagnosis and possible diagnosis in Goodpasture's Syndrome. A linear fluorescence along the Glomerular Basement Membrane can be observed in most Goodpasture's patients.
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)Immunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533002028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533002028008455330020288455330020280845533002028

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular basement membrane antibody (Goodpasture 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 glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

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

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