FDA.reportPublic FDA data

Anti-HbF FITC

Primary DI
08719327450956
Brand
Anti-HbF FITC
Company
IQ Products B.V.
Model
IQP-567F
Catalog number
IQP-567F
Device description
The FITC conjugated monoclonal antibody anti-Hemoglobin F (HbF1) reacts with the y-chain of the human fetal hemoglobin molecule in its intact form.
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
08719327450956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327450956087193274509568719327450956

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin F (HbF) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of haemoglobin subtype F (HbF), also known as foetal haemoglobin, 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08721264790002Anti-HbF R-PEIQP-578RIQP-578R2024-11-13
08719327451007Anti-panHb APCIQP-575AIQP-575A2023-07-19
08719327450949Anti-HbF PUREIQP-567PIQP-567P2023-01-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
00810227730211Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429820Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429837Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429844Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429851Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730228Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19
00810227730198Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810227730204Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810034704306Spark Violet™ 538 anti-human CD4BIOLEGEND, INC.MVU2026-07-06
00810034704337Spark Violet™ 423 anti-human CD45BIOLEGEND, INC.MVU2026-07-06
15099590807160Anti-TCR Cß1 (TRBC1)-FITCIMMUNOTECHMVU2026-06-25
05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06