FDA.reportPublic FDA data

CD64 CyQ

Primary DI
08719327451069
Brand
CD64 CyQ
Company
IQ Products B.V.
Model
IQP-568C
Catalog number
IQP-568C
Device description
The CyQ conjugated monoclonal antibody CD64 (clone 22) binds to a CD64 epitope distinct from the ligand-binding site and from the clone 32.2 antibody to CD64 epitope. It shows especially high affinity binding to human mononuclear phagocytes and polymorphonuclear leukocytes exposed to IFN-y or G-CSF. Its binding is not blocked in the presence of human IgG or immune complexes.CD64 reacts with the Fc gamma receptor 1 (FcyR1), a glycoprotein with a molecular weight of 72 kDa.The antigen is a high-affinity receptor for IgG and is able to bind human IgG1 and IgG3. The antigen is expressed on macrophages, monocytes, and interferon y (IFN-y) and Granulocyte Colony Stimulating Factor (G-CSF) stimulated neutrophils.
Published
2023-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719327451069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327451069087193274510698719327451069

GMDN Terms#

Term, Definition table
TermDefinition
CD64 cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD64 cell marker in a clinical specimen.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+31505757000orders@iqproducts.nl

Regulatory Flags#

DUNS number
490578678
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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