FDA.reportPublic FDA data

Anti-panHb APC

Primary DI
08719327451007
Brand
Anti-panHb APC
Company
IQ Products B.V.
Model
IQP-575A
Catalog number
IQP-575A
Device description
The APC conjugated monoclonal antibody anti-pan Hemoglobin (panHb) antibody recognizes the α-chain of human hemoglobin.
Published
2023-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08719327451007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327451007087193274510078719327451007

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin detection 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 haemoglobin in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08721264790002Anti-HbF R-PEIQP-578RIQP-578R2024-11-13
08719327450949Anti-HbF PUREIQP-567PIQP-567P2023-01-26
08719327450956Anti-HbF FITCIQP-567FIQP-567F2023-01-26
08719327450963Anti-HbF R-PEIQP-567RIQP-567R2023-01-26
08719327450970Anti-HbF Dy-410IQP-567DIQP-567D2023-01-26
08719327450987anti-HbS PUREIQP-574PIQP-574P2023-01-26
08719327450994anti-HbS FITCIQP-574FIQP-574F2023-01-26
08719327451014CD163 PURE IQP-570PIQP-570P2023-01-26
08719327451021CD163 FITCIQP-570FIQP-570F2023-01-26
08719327451038CD163 R-PEIQP-570RIQP-570R2023-01-26
08719327451045CD163 BiotinIQP-570BIQP-570B2023-01-26
08719327451052CD64 PUREIQP-568PIQP-568P2023-01-26
08719327451069CD64 CyQIQP-568CIQP-568C2023-01-26
08719327451076CD64 FITCIQP-568FIQP-568F2023-01-26
08719327451083CD64 R-PEIQP-568RIQP-568R2023-01-26
08719327451090CD64 R-PEIQP-569RIQP-569R2023-01-26
08717953022325CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test KitVIR-BDC100 CHSVIR-BDC100 CHS2016-09-19
08717953022349CMV Brite™, CMV antigenemia detection kitVIR-BDC100VIR-BDC1002016-09-19
08717953022301CMV Brite™ Turbo, CMV antigenemia detection kitVIR-CMV110 BDCVIR-CMV110 BDC2016-09-19
08717953022318CMV Brite™ Turbo Control SlidesVIR-CMV CS05 BDCVIR-CMV CS05 BDC2016-09-19

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